75 Ge Healthcare jobs in South Africa
Consultant Medical Devices Durban
Posted 20 days ago
Job Viewed
Job Description
We are looking for an individual who has an established network and relationships with Cardiologists. Understanding of the product portfolio is key. 'Stents' and 'Guidewires' are amongst the key products that you will be selling, and your understanding and previous sales track record will be key in landing this role.
Reporting to: Sales Manager
DUTIES & RESPONSIBILITIES:- ENSURE MARKET & PRODUCT KNOWLEDGE:
- Ensure up-to-date knowledge of the market drivers, the competition, market positioning, evolutions within the field, etc.
- Ensure a complete understanding and consideration of customer requirements.
- Meet with marketing to implement the defined appropriate product and technical support.
- ACHIEVEMENT SALES & PROFIT TARGETS:
- Manage all sales activities for his/her product group / territory.
- Set together with the Sales Manager, the targets and price levels and follow up the results.
- Assist the Sales Manager in analysing all problems related to his/her product group / territory, propose and plan corrective actions in order to reach the objectives and targets.
- Assist to obtain the gross profit of the business and the sales development for a product group / territory.
- Market mapping: examine the market conditions and identify trends in order to facilitate the strategy build by the product manager and sales manager.
- IMPLEMENT MARKETING & SALES STRATEGY:
- Implement defined strategies and develop tactics in order to improve the sales and profitability of his/her product group / territory together with sales management.
- Assist to search for new sales methods and possibilities.
- Assists in establishing the adequate sales channels and improve the quality of a product group.
- Manage the Key Opinion Leaders portfolio by proactively building and maintaining excellent relations.
- Maintain excellent relations with external official parties, authorities, and organisations.
- MANAGE CONGRESSES:
- Be present at local conferences, congresses, trade shows to represent the company towards the target market.
- TRAIN INTERNAL & EXTERNAL CUSTOMERS:
- Give and set-up training programmes for external and internal customers (search for the needs of a technical training) in collaboration with the Product Manager.
- QA/RA PROCEDURES:
- Complaint handling.
- GENERAL:
- Complete a monthly detailed report to ensure a smooth communication and information stream.
- Act as representative of the company towards many third parties.
- Assume all other responsibilities and authorities this function may require regarding new opportunities.
Skills & Experience:
- Master or Bachelor's degree.
- Min 3-5 years of relevant working experience in a similar function.
- Practical knowledge of Sales techniques.
- Preferably having a network of Vascular Surgeons and Interventional Radiologists / Interventional Cardiologists / Cardiovascular products (depending on the relevant BU).
- Acquaintance and knowledge of the local market is a considerable asset.
- Be a flexible team player, able to work independently, prioritize own work, and maintain confidentiality of information.
- Have a positive attitude and be pro-active, with excellent organizational, communication, and interpersonal skills, and be able to work under pressure and within short time constraints. Show drive and determination for all tasks.
Benefits include:
Medical Aid.
Provident Fund.
Reimbursive Travel.
Commission.
Access to company-specific training programs and software.
Consultant medical devices durban
Posted today
Job Viewed
Job Description
Medical devices QMS ISO13485 auditor
Posted 2 days ago
Job Viewed
Job Description
Overview
Position: Medical devices assessor
Location: South Korea (home based)
Responsibilities- As a RS Client Manager (Assessor) you'll be responsible for frequently travelling and having overnight stays across South Korea. You'll assess to ISO 13485 quality management systems, EU medical device regulations and MDSAP scheme on customer sites, write up comprehensive reports and present these to the client. You'll also have the opportunity for occasional international travel to the USA and Europe.
- You'll undertake extensive training to deliver in your role. This includes: ISO13485 Lead Auditor course, MDSAP (Medical Device Single Audit Programme), and MDR (Medical Device Regulation).
- BSI (British Standards Institution) is the global business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence.
- Our Regulatory Services team ensure patient safety while supporting timely market access for our clients Medical Device products globally. BSI has successfully achieved designation as a Notified Body in The Netherlands, is an accredited ISO 13485 Certification Body and is recognized in many global markets.
- Undertake management system assessments in accordance with BSI requirements.
- Prepare assessment reports and deliver findings to clients to ensure client understanding of the assessment decision and clear direction to particular items of corrective action where appropriate.
- Recommend the issue, re-issue or withdrawal of certificates, and report recommendations in accordance with BSI policy, procedures and prescribed time frame.
- Lead assessment teams as required ensuring that team members are adequately briefed so that quality of service is maintained and that effective working relationships are sustained both with Clients and within the team
- Establish and develop an effective partnership, which secures the commercial relationship and encourages opportunities for business development and increased client satisfaction with clients in your portfolio.
- Provide accurate and prompt information to support services, working closely with them to ensure that client records are up to date and complete and that all other internal information requirements are met.
- Plan/schedule workloads to make best use of own time and maximise revenue-earning activity.
- Coach colleagues as appropriate especially where those members are inexperienced assessors or unfamiliar with clients' business/technology and assist in the induction and coaching of new colleagues as requested.
- Maintain and develop assessment skills and technical and management system standards knowledge.
- Provide technical support to clients through business development, sales and customer service staff
- Act as a brand Ambassador for BSI. This means acting ethically, following company rules and promoting BSI services to clients so they are able to optimize business performance and “Make Excellence a Habit”.
- Bachelor degree or above with medical device industry related major or main professional qualification in a relevant subject and have a comprehensive knowledge of ISO 13485 and EU medical device regulation *
- Minimum 5 years quality management and technology management working experience in the fields of Medical devices with biological active coatings and / or materials or being wholly or mainly absorbed or locally dispersed in the human body; Active medical device or active implantable device. IVD devices manufactured using metal or plastic processing, IVD devices manufactured using non-metal mineral processing, (e.g. glass, ceramics, textiles, rubber, leather, paper)
- Commercial understanding of compliance industry, minimum 2 years quality system management
- Knowledge of business processes and application of quality management standards
- Good verbal and written communication skills and an eye for detail
- Be self motivated, flexible, and have excellent time management/planning skills
- Can work under pressure
- Willing to travel on business intensively
- An enthusiastic and committed team player
- Good public speaking and business development skill will be considered advantageous
- Delivery of man-days as booked in time and good quality work together with positive feedback from clients
- Feedback efficiently to both clients and internal queries
- Timely submission of reports
- Actively solve problems when needed with “can do” attitude
- Add value to clients by identifying their needs and introducing multiple BSI services to improve clients business performance and help them “Make excellence a habit”
- Help to avoid customer attrition by providing quality value added service and technical support
- Native Korean speaking and local hire.
Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.
BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.
#J-18808-LjbffrMedical devices QMS ISO13485 auditor
Posted 2 days ago
Job Viewed
Job Description
Overview
Position: Medical devices assessor
Location: South Korea (home based)
Responsibilities- As a RS Client Manager (Assessor) you'll be responsible for frequently travelling and having overnight stays across South Korea. You'll assess to ISO 13485 quality management systems, EU medical device regulations and MDSAP scheme on customer sites, write up comprehensive reports and present these to the client. You'll also have the opportunity for occasional international travel to the USA and Europe.
- You'll undertake extensive training to deliver in your role. This includes: ISO13485 Lead Auditor course, MDSAP (Medical Device Single Audit Programme), and MDR (Medical Device Regulation).
- BSI (British Standards Institution) is the global business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence.
- Our Regulatory Services team ensure patient safety while supporting timely market access for our clients Medical Device products globally. BSI has successfully achieved designation as a Notified Body in The Netherlands, is an accredited ISO 13485 Certification Body and is recognized in many global markets.
- Undertake management system assessments in accordance with BSI requirements.
- Prepare assessment reports and deliver findings to clients to ensure client understanding of the assessment decision and clear direction to particular items of corrective action where appropriate.
- Recommend the issue, re-issue or withdrawal of certificates, and report recommendations in accordance with BSI policy, procedures and prescribed time frame.
- Lead assessment teams as required ensuring that team members are adequately briefed so that quality of service is maintained and that effective working relationships are sustained both with Clients and within the team
- Establish and develop an effective partnership, which secures the commercial relationship and encourages opportunities for business development and increased client satisfaction with clients in your portfolio.
- Provide accurate and prompt information to support services, working closely with them to ensure that client records are up to date and complete and that all other internal information requirements are met.
- Plan/schedule workloads to make best use of own time and maximise revenue-earning activity.
- Coach colleagues as appropriate especially where those members are inexperienced assessors or unfamiliar with clients' business/technology and assist in the induction and coaching of new colleagues as requested.
- Maintain and develop assessment skills and technical and management system standards knowledge.
- Provide technical support to clients through business development, sales and customer service staff
- Act as a brand Ambassador for BSI. This means acting ethically, following company rules and promoting BSI services to clients so they are able to optimize business performance and “Make Excellence a Habit”.
- Bachelor degree or above with medical device industry related major or main professional qualification in a relevant subject and have a comprehensive knowledge of ISO 13485 and EU medical device regulation *
- Minimum 5 years quality management and technology management working experience in the fields of Medical devices with biological active coatings and / or materials or being wholly or mainly absorbed or locally dispersed in the human body; Active medical device or active implantable device. IVD devices manufactured using metal or plastic processing, IVD devices manufactured using non-metal mineral processing, (e.g. glass, ceramics, textiles, rubber, leather, paper)
- Commercial understanding of compliance industry, minimum 2 years quality system management
- Knowledge of business processes and application of quality management standards
- Good verbal and written communication skills and an eye for detail
- Be self motivated, flexible, and have excellent time management/planning skills
- Can work under pressure
- Willing to travel on business intensively
- An enthusiastic and committed team player
- Good public speaking and business development skill will be considered advantageous
- Delivery of man-days as booked in time and good quality work together with positive feedback from clients
- Feedback efficiently to both clients and internal queries
- Timely submission of reports
- Actively solve problems when needed with “can do” attitude
- Add value to clients by identifying their needs and introducing multiple BSI services to improve clients business performance and help them “Make excellence a habit”
- Help to avoid customer attrition by providing quality value added service and technical support
- Native Korean speaking and local hire.
Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.
BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.
#J-18808-LjbffrMedical devices QMS ISO13485 auditor
Posted 2 days ago
Job Viewed
Job Description
Overview
Position: Medical devices assessor
Location: South Korea (home based)
Responsibilities- As a RS Client Manager (Assessor) you'll be responsible for frequently travelling and having overnight stays across South Korea. You'll assess to ISO 13485 quality management systems, EU medical device regulations and MDSAP scheme on customer sites, write up comprehensive reports and present these to the client. You'll also have the opportunity for occasional international travel to the USA and Europe.
- You'll undertake extensive training to deliver in your role. This includes: ISO13485 Lead Auditor course, MDSAP (Medical Device Single Audit Programme), and MDR (Medical Device Regulation).
- BSI (British Standards Institution) is the global business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence.
- Our Regulatory Services team ensure patient safety while supporting timely market access for our clients Medical Device products globally. BSI has successfully achieved designation as a Notified Body in The Netherlands, is an accredited ISO 13485 Certification Body and is recognized in many global markets.
- Undertake management system assessments in accordance with BSI requirements.
- Prepare assessment reports and deliver findings to clients to ensure client understanding of the assessment decision and clear direction to particular items of corrective action where appropriate.
- Recommend the issue, re-issue or withdrawal of certificates, and report recommendations in accordance with BSI policy, procedures and prescribed time frame.
- Lead assessment teams as required ensuring that team members are adequately briefed so that quality of service is maintained and that effective working relationships are sustained both with Clients and within the team
- Establish and develop an effective partnership, which secures the commercial relationship and encourages opportunities for business development and increased client satisfaction with clients in your portfolio.
- Provide accurate and prompt information to support services, working closely with them to ensure that client records are up to date and complete and that all other internal information requirements are met.
- Plan/schedule workloads to make best use of own time and maximise revenue-earning activity.
- Coach colleagues as appropriate especially where those members are inexperienced assessors or unfamiliar with clients' business/technology and assist in the induction and coaching of new colleagues as requested.
- Maintain and develop assessment skills and technical and management system standards knowledge.
- Provide technical support to clients through business development, sales and customer service staff
- Act as a brand Ambassador for BSI. This means acting ethically, following company rules and promoting BSI services to clients so they are able to optimize business performance and “Make Excellence a Habit”.
- Bachelor degree or above with medical device industry related major or main professional qualification in a relevant subject and have a comprehensive knowledge of ISO 13485 and EU medical device regulation *
- Minimum 5 years quality management and technology management working experience in the fields of Medical devices with biological active coatings and / or materials or being wholly or mainly absorbed or locally dispersed in the human body; Active medical device or active implantable device. IVD devices manufactured using metal or plastic processing, IVD devices manufactured using non-metal mineral processing, (e.g. glass, ceramics, textiles, rubber, leather, paper)
- Commercial understanding of compliance industry, minimum 2 years quality system management
- Knowledge of business processes and application of quality management standards
- Good verbal and written communication skills and an eye for detail
- Be self motivated, flexible, and have excellent time management/planning skills
- Can work under pressure
- Willing to travel on business intensively
- An enthusiastic and committed team player
- Good public speaking and business development skill will be considered advantageous
- Delivery of man-days as booked in time and good quality work together with positive feedback from clients
- Feedback efficiently to both clients and internal queries
- Timely submission of reports
- Actively solve problems when needed with “can do” attitude
- Add value to clients by identifying their needs and introducing multiple BSI services to improve clients business performance and help them “Make excellence a habit”
- Help to avoid customer attrition by providing quality value added service and technical support
- Native Korean speaking and local hire.
Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.
BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.
#J-18808-LjbffrMedical devices QMS ISO13485 auditor
Posted 2 days ago
Job Viewed
Job Description
Overview
Position: Medical devices assessor
Location: South Korea (home based)
Responsibilities- As a RS Client Manager (Assessor) you'll be responsible for frequently travelling and having overnight stays across South Korea. You'll assess to ISO 13485 quality management systems, EU medical device regulations and MDSAP scheme on customer sites, write up comprehensive reports and present these to the client. You'll also have the opportunity for occasional international travel to the USA and Europe.
- You'll undertake extensive training to deliver in your role. This includes: ISO13485 Lead Auditor course, MDSAP (Medical Device Single Audit Programme), and MDR (Medical Device Regulation).
- BSI (British Standards Institution) is the global business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence.
- Our Regulatory Services team ensure patient safety while supporting timely market access for our clients Medical Device products globally. BSI has successfully achieved designation as a Notified Body in The Netherlands, is an accredited ISO 13485 Certification Body and is recognized in many global markets.
- Undertake management system assessments in accordance with BSI requirements.
- Prepare assessment reports and deliver findings to clients to ensure client understanding of the assessment decision and clear direction to particular items of corrective action where appropriate.
- Recommend the issue, re-issue or withdrawal of certificates, and report recommendations in accordance with BSI policy, procedures and prescribed time frame.
- Lead assessment teams as required ensuring that team members are adequately briefed so that quality of service is maintained and that effective working relationships are sustained both with Clients and within the team
- Establish and develop an effective partnership, which secures the commercial relationship and encourages opportunities for business development and increased client satisfaction with clients in your portfolio.
- Provide accurate and prompt information to support services, working closely with them to ensure that client records are up to date and complete and that all other internal information requirements are met.
- Plan/schedule workloads to make best use of own time and maximise revenue-earning activity.
- Coach colleagues as appropriate especially where those members are inexperienced assessors or unfamiliar with clients' business/technology and assist in the induction and coaching of new colleagues as requested.
- Maintain and develop assessment skills and technical and management system standards knowledge.
- Provide technical support to clients through business development, sales and customer service staff
- Act as a brand Ambassador for BSI. This means acting ethically, following company rules and promoting BSI services to clients so they are able to optimize business performance and “Make Excellence a Habit”.
- Bachelor degree or above with medical device industry related major or main professional qualification in a relevant subject and have a comprehensive knowledge of ISO 13485 and EU medical device regulation *
- Minimum 5 years quality management and technology management working experience in the fields of Medical devices with biological active coatings and / or materials or being wholly or mainly absorbed or locally dispersed in the human body; Active medical device or active implantable device. IVD devices manufactured using metal or plastic processing, IVD devices manufactured using non-metal mineral processing, (e.g. glass, ceramics, textiles, rubber, leather, paper)
- Commercial understanding of compliance industry, minimum 2 years quality system management
- Knowledge of business processes and application of quality management standards
- Good verbal and written communication skills and an eye for detail
- Be self motivated, flexible, and have excellent time management/planning skills
- Can work under pressure
- Willing to travel on business intensively
- An enthusiastic and committed team player
- Good public speaking and business development skill will be considered advantageous
- Delivery of man-days as booked in time and good quality work together with positive feedback from clients
- Feedback efficiently to both clients and internal queries
- Timely submission of reports
- Actively solve problems when needed with “can do” attitude
- Add value to clients by identifying their needs and introducing multiple BSI services to improve clients business performance and help them “Make excellence a habit”
- Help to avoid customer attrition by providing quality value added service and technical support
- Native Korean speaking and local hire.
Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.
BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.
#J-18808-LjbffrMedical devices QMS ISO13485 auditor
Posted 2 days ago
Job Viewed
Job Description
Overview
Position: Medical devices assessor
Location: South Korea (home based)
Responsibilities- As a RS Client Manager (Assessor) you'll be responsible for frequently travelling and having overnight stays across South Korea. You'll assess to ISO 13485 quality management systems, EU medical device regulations and MDSAP scheme on customer sites, write up comprehensive reports and present these to the client. You'll also have the opportunity for occasional international travel to the USA and Europe.
- You'll undertake extensive training to deliver in your role. This includes: ISO13485 Lead Auditor course, MDSAP (Medical Device Single Audit Programme), and MDR (Medical Device Regulation).
- BSI (British Standards Institution) is the global business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence.
- Our Regulatory Services team ensure patient safety while supporting timely market access for our clients Medical Device products globally. BSI has successfully achieved designation as a Notified Body in The Netherlands, is an accredited ISO 13485 Certification Body and is recognized in many global markets.
- Undertake management system assessments in accordance with BSI requirements.
- Prepare assessment reports and deliver findings to clients to ensure client understanding of the assessment decision and clear direction to particular items of corrective action where appropriate.
- Recommend the issue, re-issue or withdrawal of certificates, and report recommendations in accordance with BSI policy, procedures and prescribed time frame.
- Lead assessment teams as required ensuring that team members are adequately briefed so that quality of service is maintained and that effective working relationships are sustained both with Clients and within the team
- Establish and develop an effective partnership, which secures the commercial relationship and encourages opportunities for business development and increased client satisfaction with clients in your portfolio.
- Provide accurate and prompt information to support services, working closely with them to ensure that client records are up to date and complete and that all other internal information requirements are met.
- Plan/schedule workloads to make best use of own time and maximise revenue-earning activity.
- Coach colleagues as appropriate especially where those members are inexperienced assessors or unfamiliar with clients' business/technology and assist in the induction and coaching of new colleagues as requested.
- Maintain and develop assessment skills and technical and management system standards knowledge.
- Provide technical support to clients through business development, sales and customer service staff
- Act as a brand Ambassador for BSI. This means acting ethically, following company rules and promoting BSI services to clients so they are able to optimize business performance and “Make Excellence a Habit”.
- Bachelor degree or above with medical device industry related major or main professional qualification in a relevant subject and have a comprehensive knowledge of ISO 13485 and EU medical device regulation *
- Minimum 5 years quality management and technology management working experience in the fields of Medical devices with biological active coatings and / or materials or being wholly or mainly absorbed or locally dispersed in the human body; Active medical device or active implantable device. IVD devices manufactured using metal or plastic processing, IVD devices manufactured using non-metal mineral processing, (e.g. glass, ceramics, textiles, rubber, leather, paper)
- Commercial understanding of compliance industry, minimum 2 years quality system management
- Knowledge of business processes and application of quality management standards
- Good verbal and written communication skills and an eye for detail
- Be self motivated, flexible, and have excellent time management/planning skills
- Can work under pressure
- Willing to travel on business intensively
- An enthusiastic and committed team player
- Good public speaking and business development skill will be considered advantageous
- Delivery of man-days as booked in time and good quality work together with positive feedback from clients
- Feedback efficiently to both clients and internal queries
- Timely submission of reports
- Actively solve problems when needed with “can do” attitude
- Add value to clients by identifying their needs and introducing multiple BSI services to improve clients business performance and help them “Make excellence a habit”
- Help to avoid customer attrition by providing quality value added service and technical support
- Native Korean speaking and local hire.
Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.
BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.
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Medical devices QMS ISO13485 auditor
Posted 2 days ago
Job Viewed
Job Description
Overview
Position: Medical devices assessor
Location: South Korea (home based)
Responsibilities- As a RS Client Manager (Assessor) you'll be responsible for frequently travelling and having overnight stays across South Korea. You'll assess to ISO 13485 quality management systems, EU medical device regulations and MDSAP scheme on customer sites, write up comprehensive reports and present these to the client. You'll also have the opportunity for occasional international travel to the USA and Europe.
- You'll undertake extensive training to deliver in your role. This includes: ISO13485 Lead Auditor course, MDSAP (Medical Device Single Audit Programme), and MDR (Medical Device Regulation).
- BSI (British Standards Institution) is the global business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence.
- Our Regulatory Services team ensure patient safety while supporting timely market access for our clients Medical Device products globally. BSI has successfully achieved designation as a Notified Body in The Netherlands, is an accredited ISO 13485 Certification Body and is recognized in many global markets.
- Undertake management system assessments in accordance with BSI requirements.
- Prepare assessment reports and deliver findings to clients to ensure client understanding of the assessment decision and clear direction to particular items of corrective action where appropriate.
- Recommend the issue, re-issue or withdrawal of certificates, and report recommendations in accordance with BSI policy, procedures and prescribed time frame.
- Lead assessment teams as required ensuring that team members are adequately briefed so that quality of service is maintained and that effective working relationships are sustained both with Clients and within the team
- Establish and develop an effective partnership, which secures the commercial relationship and encourages opportunities for business development and increased client satisfaction with clients in your portfolio.
- Provide accurate and prompt information to support services, working closely with them to ensure that client records are up to date and complete and that all other internal information requirements are met.
- Plan/schedule workloads to make best use of own time and maximise revenue-earning activity.
- Coach colleagues as appropriate especially where those members are inexperienced assessors or unfamiliar with clients' business/technology and assist in the induction and coaching of new colleagues as requested.
- Maintain and develop assessment skills and technical and management system standards knowledge.
- Provide technical support to clients through business development, sales and customer service staff
- Act as a brand Ambassador for BSI. This means acting ethically, following company rules and promoting BSI services to clients so they are able to optimize business performance and “Make Excellence a Habit”.
- Bachelor degree or above with medical device industry related major or main professional qualification in a relevant subject and have a comprehensive knowledge of ISO 13485 and EU medical device regulation *
- Minimum 5 years quality management and technology management working experience in the fields of Medical devices with biological active coatings and / or materials or being wholly or mainly absorbed or locally dispersed in the human body; Active medical device or active implantable device. IVD devices manufactured using metal or plastic processing, IVD devices manufactured using non-metal mineral processing, (e.g. glass, ceramics, textiles, rubber, leather, paper)
- Commercial understanding of compliance industry, minimum 2 years quality system management
- Knowledge of business processes and application of quality management standards
- Good verbal and written communication skills and an eye for detail
- Be self motivated, flexible, and have excellent time management/planning skills
- Can work under pressure
- Willing to travel on business intensively
- An enthusiastic and committed team player
- Good public speaking and business development skill will be considered advantageous
- Delivery of man-days as booked in time and good quality work together with positive feedback from clients
- Feedback efficiently to both clients and internal queries
- Timely submission of reports
- Actively solve problems when needed with “can do” attitude
- Add value to clients by identifying their needs and introducing multiple BSI services to improve clients business performance and help them “Make excellence a habit”
- Help to avoid customer attrition by providing quality value added service and technical support
- Native Korean speaking and local hire.
Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.
BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.
#J-18808-LjbffrMedical devices QMS ISO13485 auditor
Posted 2 days ago
Job Viewed
Job Description
Overview
Position: Medical devices assessor
Location: South Korea (home based)
Responsibilities- As a RS Client Manager (Assessor) you'll be responsible for frequently travelling and having overnight stays across South Korea. You'll assess to ISO 13485 quality management systems, EU medical device regulations and MDSAP scheme on customer sites, write up comprehensive reports and present these to the client. You'll also have the opportunity for occasional international travel to the USA and Europe.
- You'll undertake extensive training to deliver in your role. This includes: ISO13485 Lead Auditor course, MDSAP (Medical Device Single Audit Programme), and MDR (Medical Device Regulation).
- BSI (British Standards Institution) is the global business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence.
- Our Regulatory Services team ensure patient safety while supporting timely market access for our clients Medical Device products globally. BSI has successfully achieved designation as a Notified Body in The Netherlands, is an accredited ISO 13485 Certification Body and is recognized in many global markets.
- Undertake management system assessments in accordance with BSI requirements.
- Prepare assessment reports and deliver findings to clients to ensure client understanding of the assessment decision and clear direction to particular items of corrective action where appropriate.
- Recommend the issue, re-issue or withdrawal of certificates, and report recommendations in accordance with BSI policy, procedures and prescribed time frame.
- Lead assessment teams as required ensuring that team members are adequately briefed so that quality of service is maintained and that effective working relationships are sustained both with Clients and within the team
- Establish and develop an effective partnership, which secures the commercial relationship and encourages opportunities for business development and increased client satisfaction with clients in your portfolio.
- Provide accurate and prompt information to support services, working closely with them to ensure that client records are up to date and complete and that all other internal information requirements are met.
- Plan/schedule workloads to make best use of own time and maximise revenue-earning activity.
- Coach colleagues as appropriate especially where those members are inexperienced assessors or unfamiliar with clients' business/technology and assist in the induction and coaching of new colleagues as requested.
- Maintain and develop assessment skills and technical and management system standards knowledge.
- Provide technical support to clients through business development, sales and customer service staff
- Act as a brand Ambassador for BSI. This means acting ethically, following company rules and promoting BSI services to clients so they are able to optimize business performance and “Make Excellence a Habit”.
- Bachelor degree or above with medical device industry related major or main professional qualification in a relevant subject and have a comprehensive knowledge of ISO 13485 and EU medical device regulation *
- Minimum 5 years quality management and technology management working experience in the fields of Medical devices with biological active coatings and / or materials or being wholly or mainly absorbed or locally dispersed in the human body; Active medical device or active implantable device. IVD devices manufactured using metal or plastic processing, IVD devices manufactured using non-metal mineral processing, (e.g. glass, ceramics, textiles, rubber, leather, paper)
- Commercial understanding of compliance industry, minimum 2 years quality system management
- Knowledge of business processes and application of quality management standards
- Good verbal and written communication skills and an eye for detail
- Be self motivated, flexible, and have excellent time management/planning skills
- Can work under pressure
- Willing to travel on business intensively
- An enthusiastic and committed team player
- Good public speaking and business development skill will be considered advantageous
- Delivery of man-days as booked in time and good quality work together with positive feedback from clients
- Feedback efficiently to both clients and internal queries
- Timely submission of reports
- Actively solve problems when needed with “can do” attitude
- Add value to clients by identifying their needs and introducing multiple BSI services to improve clients business performance and help them “Make excellence a habit”
- Help to avoid customer attrition by providing quality value added service and technical support
- Native Korean speaking and local hire.
Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.
BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.
#J-18808-LjbffrMedical devices QMS ISO13485 auditor
Posted 2 days ago
Job Viewed
Job Description
Overview
Position: Medical devices assessor
Location: South Korea (home based)
Responsibilities- As a RS Client Manager (Assessor) you'll be responsible for frequently travelling and having overnight stays across South Korea. You'll assess to ISO 13485 quality management systems, EU medical device regulations and MDSAP scheme on customer sites, write up comprehensive reports and present these to the client. You'll also have the opportunity for occasional international travel to the USA and Europe.
- You'll undertake extensive training to deliver in your role. This includes: ISO13485 Lead Auditor course, MDSAP (Medical Device Single Audit Programme), and MDR (Medical Device Regulation).
- BSI (British Standards Institution) is the global business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence.
- Our Regulatory Services team ensure patient safety while supporting timely market access for our clients Medical Device products globally. BSI has successfully achieved designation as a Notified Body in The Netherlands, is an accredited ISO 13485 Certification Body and is recognized in many global markets.
- Undertake management system assessments in accordance with BSI requirements.
- Prepare assessment reports and deliver findings to clients to ensure client understanding of the assessment decision and clear direction to particular items of corrective action where appropriate.
- Recommend the issue, re-issue or withdrawal of certificates, and report recommendations in accordance with BSI policy, procedures and prescribed time frame.
- Lead assessment teams as required ensuring that team members are adequately briefed so that quality of service is maintained and that effective working relationships are sustained both with Clients and within the team
- Establish and develop an effective partnership, which secures the commercial relationship and encourages opportunities for business development and increased client satisfaction with clients in your portfolio.
- Provide accurate and prompt information to support services, working closely with them to ensure that client records are up to date and complete and that all other internal information requirements are met.
- Plan/schedule workloads to make best use of own time and maximise revenue-earning activity.
- Coach colleagues as appropriate especially where those members are inexperienced assessors or unfamiliar with clients' business/technology and assist in the induction and coaching of new colleagues as requested.
- Maintain and develop assessment skills and technical and management system standards knowledge.
- Provide technical support to clients through business development, sales and customer service staff
- Act as a brand Ambassador for BSI. This means acting ethically, following company rules and promoting BSI services to clients so they are able to optimize business performance and “Make Excellence a Habit”.
- Bachelor degree or above with medical device industry related major or main professional qualification in a relevant subject and have a comprehensive knowledge of ISO 13485 and EU medical device regulation *
- Minimum 5 years quality management and technology management working experience in the fields of Medical devices with biological active coatings and / or materials or being wholly or mainly absorbed or locally dispersed in the human body; Active medical device or active implantable device. IVD devices manufactured using metal or plastic processing, IVD devices manufactured using non-metal mineral processing, (e.g. glass, ceramics, textiles, rubber, leather, paper)
- Commercial understanding of compliance industry, minimum 2 years quality system management
- Knowledge of business processes and application of quality management standards
- Good verbal and written communication skills and an eye for detail
- Be self motivated, flexible, and have excellent time management/planning skills
- Can work under pressure
- Willing to travel on business intensively
- An enthusiastic and committed team player
- Good public speaking and business development skill will be considered advantageous
- Delivery of man-days as booked in time and good quality work together with positive feedback from clients
- Feedback efficiently to both clients and internal queries
- Timely submission of reports
- Actively solve problems when needed with “can do” attitude
- Add value to clients by identifying their needs and introducing multiple BSI services to improve clients business performance and help them “Make excellence a habit”
- Help to avoid customer attrition by providing quality value added service and technical support
- Native Korean speaking and local hire.
Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.
BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.
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