23 Regulatory Affairs jobs in South Africa

BIOVAC is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to "protect life". We are looking to hire a dynamic, passionate, confident, proactive and meticulous Regulatory Affairs Pharmacist to join a goal-oriented team.

QUALIFICATIONS NEEDED:

• Bachelor’s degree in pharmacy
• Pharmacist registration with SAPC

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

• 5 years related experience in vaccine / biotech / pharmaceutical industry or equivalent
• Thorough knowledge of the current Medicines and Related Substances Act 101 and the Pharmacy Act 57 and current regulatory policies and guidelines of SAHPRA and their implication to the company.
• Experience in Pharmaceutical Regulatory Affairs aspects (Medicine registration and legal compliance) and documentation management and product maintenance related to the product portfolio
• Experience in quality and regulatory compliance within a cGMP facility.
• Program and project management
• Experience in registering product in ZAZIBONA /EAC-AMRH
• Experience in having faced successfully local and/ or international quality audits.
• Experience in eCTD compilation

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

Core Technical Delivery:

• Maintenance and monitoring of existing registration dossiers (amendments and updates) including timeous responses to resolutions from NRA’s by receiving and submitting all applicable updates, post-registration amendments, resolutions and any other correspondence required by the SAHPRA or any other applicable regulatory authority in accordance with current guidelines and within the specified timelines in order to support the strategic business objectives and close any compliance gaps as quickly as possible.
• Preparing and submitting post-registration clinical updates to package inserts and patient information leaflets in line with current SAHPRA guidelines and regulations.
• Perform due diligence audits of existing and new product regulatory dossiers.
• Author, compile, publish and submit new registration dossiers to NRA’s in the required format for local (SA) and identified export markets for new products and when applicable work in conjunction with consultants to achieve submission.
• Completion of applicable Section 36 Exemption, Section 21 and Clinical Trial Applications.
• Update and maintain dossiers to latest requirements
• Identify key opportunities and deliverables as required by the department or by other departments for cross functional synergies/ project work.
• Provides regulatory advice when required to relevant stakeholders including sales, marketing, supply chain, medical and commercial team with regards to the products.
• Assist RA HOD in follow ups / responses on regulatory audits by third party / NRA
• Regulatory Intelligence: Assist RA HOD to Identify anticipated risks impacting department/ section/ team / keeping business abreast of regulatory developments, trends) and changes in the local regulatory and international environment which directly impacts Biovac products. Effectively communicating these changes so that all relevant stakeholders may assess the impact on the business.
• Request and obtain Import & Export Permits
• Writing / Reviewing and / updating of Regulatory SOP’s (comprehensive and up to date and revised as per internal plan)
• Assist and or provide guidance in opening and close out of delegated Change Controls/ NCR’s / CAPA’s in order to support QA’s processes.
• Review and approve artwork for packaging material to ensure compliance with regulatory requirements.
• Maintain and establish relationships with the SAHPRA units and/or other Health Authorities to ensure more effective streamlining of the company’s applications when required
• Ensure that the Document Database is kept in good order by completing the required administrative activities for appropriate maintenance, co-ordination and accuracy of all dossiers and correspondence
• Approve promotional material (advertising)
• Assist in establishing the annual regulatory budget

Application Deadline: 15 August 2025

If you do not receive a response from us within three weeks of submitting your application, please understand that your application was not successful.

We believe in the magic of diversity within teams and to achieve this, we do apply Employment Equity principles during our selection process where this is necessary to achieve such diversity.

Disclaimer:

Dear Applicant, we appreciate your interest in joining our organisation. It is imperative for us that you understand how we handle your information. We are committed to ensuring the security and confidentiality of the information you provide. Your personal details will be collected for the sole purpose of the application process and will be used strictly for that purpose. By applying, you acknowledge and consent to the collection, use, and protection of your personal information in accordance with our privacy policy. If you have any inquiries or concerns, our Human Capital department is available to provide clarification. We look forward to reviewing your application.’’

Do you want to be responsible for product safety and product compliance? Are you or do you want to become the Regulatory Affairs Specialist who is motivated by co-operating with all departments and interacting with external parties like customers and authorities? IGM is looking for a new global team member that fits these criteria!

This job can be done from Waalwijk, NL or from Gerenzano, Italy

You will be globally assessing the impact of new and emerging legislation. You set up and manage product registrations. If there are discrepancies in compliance you will highlight them and work to correct these. Besides the internal contacts, you will be the liaison between our organization and external consultants to ensure projects are on target and on budget.

Furthermore, you will collaborate with external specialists (for example hazard communication specialists) and you provide support to customers through questionnaires or direct questions, to suppliers, agents, and IGM team members. Presenting regulatory updates, internally and externally, is an important part of the job.

IGM Resins is recognized as the leader in UV Technology. Headquartered in Waalwijk, the Netherlands, IGM is the world’s leading manufacturer of specialty chemicals focused on the UV Inks, coatings, and adhesives market. Manufacturing and product development activities are in Europe and Asia with sales and distribution locations strategically positioned globally to best serve regional markets.

IGM Resins has grown through organic and acquisitions over the last 5 years and currently employs around 700 team members globally.

You are an independent Regulatory specialist with commercial and business insight. You are focused on quality, and you are able to organize your own work. You have well-developed communication skills in English. Travelling will be part of the role to IGM locations, customers, or authorities.

You have a Bachelor's degree in Chemistry and/or General Science, with a minimum of 5 years working experience in an international organization focusing on compliance/regulatory affairs in the UV radiation curing industry. Familiarity with GHS, international legislation, specifically product safety issues (indirect food contact, substance migration) is a much-appreciated quality.

We work with a great and energetic group of people. We value our team members, and we will offer a generic benefit package. Development and attention to people are also very important to us! We offer a dynamic and diverse working culture. You will be working in a team with a nice mix of people with different backgrounds and experience within a growing company with a clear vision.

A place where you get a lot of responsibility and possibilities for personal development!

Did you get excited? Then we could be a match! We encourage you to get in touch with us! Please send your resume to Babette van Loon , P&O manager EMEA and/or Marco Bulloni , P&O manager Italy, via .

BIOVAC is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to "protect life". We are looking to hire a dynamic, passionate, confident, proactive and meticulous Regulatory Affairs Pharmacist to join a goal-oriented team.

QUALIFICATIONS NEEDED:

• Bachelors degree in pharmacy
• Pharmacist registration with SAPC

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

• 5 years related experience in vaccine / biotech / pharmaceutical industry or equivalent
• Thorough knowledge of the current Medicines and Related Substances Act 101 and the Pharmacy Act 57 and current regulatory policies and guidelines of SAHPRA and their implication to the company.
• Experience in Pharmaceutical Regulatory Affairs aspects (Medicine registration and legal compliance) and documentation management and product maintenance related to the product portfolio
• Experience in quality and regulatory compliance within a cGMP facility.
• Program and project management
• Experience in registering product in ZAZIBONA /EAC-AMRH
• Experience in having faced successfully local and/ or international quality audits.
• Experience in eCTD compilation

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

Core Technical Delivery:

• Maintenance and monitoring of existing registration dossiers (amendments and updates) including timeous responses to resolutions from NRAs by receiving and submitting all applicable updates, post-registration amendments, resolutions and any other correspondence required by the SAHPRA or any other applicable regulatory authority in accordance with current guidelines and within the specified timelines in order to support the strategic business objectives and close any compliance gaps as quickly as possible.
• Preparing and submitting post-registration clinical updates to package inserts and patient information leaflets in line with current SAHPRA guidelines and regulations.
• Perform due diligence audits of existing and new product regulatory dossiers.
• Author, compile, publish and submit new registration dossiers to NRAs in the required format for local (SA) and identified export markets for new products and when applicable work in conjunction with consultants to achieve submission.
• Completion of applicable Section 36 Exemption, Section 21 and Clinical Trial Applications.
• Update and maintain dossiers to latest requirements
• Identify key opportunities and deliverables as required by the department or by other departments for cross functional synergies/ project work.
• Provides regulatory advice when required to relevant stakeholders including sales, marketing, supply chain, medical and commercial team with regards to the products.
• Assist RA HOD in follow ups / responses on regulatory audits by third party / NRA
• Regulatory Intelligence: Assist RA HOD to Identify anticipated risks impacting department/ section/ team / keeping business abreast of regulatory developments, trends) and changes in the local regulatory and international environment which directly impacts Biovac products. Effectively communicating these changes so that all relevant stakeholders may assess the impact on the business.
• Request and obtain Import & Export Permits
• Writing / Reviewing and / updating of Regulatory SOPs (comprehensive and up to date and revised as per internal plan)
• Assist and or provide guidance in opening and close out of delegated Change Controls/ NCRs / CAPAs in order to support QAs processes.
• Review and approve artwork for packaging material to ensure compliance with regulatory requirements.
• Maintain and establish relationships with the SAHPRA units and/or other Health Authorities to ensure more effective streamlining of the companys applications when required
• Ensure that the Document Database is kept in good order by completing the required administrative activities for appropriate maintenance, co-ordination and accuracy of all dossiers and correspondence
• Approve promotional material (advertising)
• Assist in establishing the annual regulatory budget

Application Deadline: 15 August 2025

If you do not receive a response from us within three weeks of submitting your application, please understand that your application was not successful.

We believe in the magic of diversity within teams and to achieve this, we do apply Employment Equity principles during our selection process where this is necessary to achieve such diversity.

Disclaimer:

Dear Applicant, we appreciate your interest in joining our organisation. It is imperative for us that you understand how we handle your information. We are committed to ensuring the security and confidentiality of the information you provide. Your personal details will be collected for the sole purpose of the application process and will be used strictly for that purpose. By applying, you acknowledge and consent to the collection, use, and protection of your personal information in accordance with our privacy policy. If you have any inquiries or concerns, our Human Capital department is available to provide clarification. We look forward to reviewing your application.

Reference: DBN003453-SS-4

Job Purpose:
Lead the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio and team outputs.

Ensure legal compliance with the relevant medicine Regulatory Authorities (Country Specific where applicable), Medicines and Related Substances Control Act and South African Pharmacy Council, ensuring timeous processing of regulatory applications.

Key Responsibilities:

1. Manage work streams for- and report on the assigned group of portfolios
2. Assisting with internal product queries from relevant departments
3. Assisting with external product queries from the SAHPRA, other MRA’s and third-party stakeholders
4. Establish regulatory priorities and allocate resources and workloads
5. Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
6. Co-ordination and submission of new product applications in South Africa and other applicable territories, including but not limited to:
1. Develop regulatory strategies and implementation plans for the preparation and submission of new products
2. Conduct dossier due diligence to ensure all data gaps are addressed
3. Prepare the registration applications for submission to the regulatory authorities
4. Work in collaboration with NBD to assess regulator’s submissions requirements
5. Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines
6. Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
7. Internal training and mentoring
8. Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders
9. Formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced.
10. Manage activities such as internal audits or regulatory agency inspections
11. Ensure alignment of personal and company values

Requirements:

1. Bachelor’s degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
2. Minimum of 5 years’ experience in Regulatory Affairs, preferably in human medicines. Demonstrated experience across the product development, commercialization and maintenance lifecycle
3. Experience in use of CTD software builder and compilation of eCTD application will be an advantage.
4. Sound project management capabilities
5. Proven ability to consistently deliver to quality, time and cost standards Professional people management experience

Competencies:

1. Experience in use of CTD software builder and compilation of eCTD application will be an advantage.
2. IT skills
3. Leadership skills, management of personnel resources
4. Ability to prioritise and work to tight deadlines
5. Systems and operations analysis
6. Active learning
7. Strategic thinking
8. Ability to cope with a high degree of complexity and change
9. Cross Functional skills: Ability to network, liaise and negotiate with others
10. Ability to set standards and objectives and monitor progress
11. Complex problem solving and decision-making skills
12. Customer relationships
13. Development of people
14. Must demonstrate responsibility, excellence and collaboration and align with Company values

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on

Should you receive no feedback within 7 days, please accept your application as unsuccessful.

HR Services, Recruitment & Selection

Reference: DBN003525-SS-1
A global pharmaceutical company has a vacancy for a Regulatory Affairs Pharmacist to co-ordinate, project control and provide regulatory support for Central, East Africa and Mauritius countries.

Key Responsibilities:

• Keeping abreast of regulatory requirements in Central, East Africa and Mauritius countries.
• Ensure the completion of submissions/ variations according to Central, East Africa and Mauritius strategic plan and timelines.
• Drive registration/variation follow up strategies and find solutions to potential supply challenges.
• Ensure that labelling for Central, East Africa and Mauritius is compliant with in-country specific requirements.
• Ensure master product tracker is up to date and accurate at all times. Ensure alignment to all other trackers that are linked to the master.
• Conduct Due diligence activities.
• Co-ordinate and compile documentation for submission in Central, East Africa and Mauritius countries (New submissions/variations/RA documents) where required.
• Liaise and communicate with and support local agent in each country to meet regulatory requirements and timelines.
• Liaise and communicate with QA, Supply Chain and PV departments to ensure compliance and alignment with the various functions (including samples ordered for renewals, variations, and new submissions).
• Respond to product-specific queries from Central, East Africa and Mauritius countries where required.
• Co-ordinate internal back up and filing (electronic and hard copy) of dossiers and relevant communication.
• Download information from external portal i.e. Docubridge, sharepoint, we-transfer or regulatory drive.
• Arrange for translations of overseas documentation if required.
• Schedule Microsoft team meetings or teleconferences as needed.
• Conduct training sessions with Central, East Africa and Mauritius Team to ensure quality submissions in line with guidelines and upskilling of team members.
• Standardize folder structures and save information on NRD - Central, East Africa and Mauritius folder.
• Liaise with principals or the company with regards to outstanding information.
• Verify documents for completeness and current information.
• Compile and maintain spreadsheets and status reports as needed and upon request.
• Compilation of work map trackers to ensure visibility of tasks.
• Ensure Central, East Africa and Mauritius registrations are renewed in a timely manner and retention fees are paid as required.
• Assist with task risk management and compilation of risk plans when associated with submissions.
• Ensure the completion of all assigned Company training within the specified timelines.
• Forward all received Product Quality Complaints, Adverse Events and Medical Enquiries to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs.

• Must have a completed Bachelor of Pharmacy Degree and/or equivalent.
• 3-5 years’ experience in pharmaceutical industry (Regulatory Affairs/ Quality/ Production).
• Should have a sound knowledge of Sub-Saharan countries regulatory requirements and guidelines.
• Must have experience and understanding of electronic document management systems / eCTD.
• High level Computer literacy.
• People skills – highly adapted interpersonal skills.
• Problem solving analysis skills.
• Priority setting – initiative and follow through.
• Time management and ability to self-motivate.
• Strong attention to detail.
• Ability to work under pressure.
• Embodies Values & Behaviours in all internal and external interactions.

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on Should you receive no feedback within 7 days, please accept your application as unsuccessful.

• HR Services, Recruitment & Selection

A Regulatory Affairs Associate is primarily responsible for ensuring that the company complies with all the regulations and laws pertaining to the business. He/she works with regulatory agencies and personnel on specific regulatory issues affecting the business. Advises the company on the regulatory aspects and offers the company options based on the proposed activities and protects current markets from regulatory related threats.

• Keeping track of the ever-changing legislation in all the regions in which Kemin distributes its products and participates in law making in those regions.
• Keeping track of the ever-changing legislation in all the regions in which Kemin imports and exports its plant material and participates in law making in those regions.
• Following and maintaining an environment of food and feed safety in compliance with rules and regulations, as applicable.
• Following and maintaining plant health and plant production rules and regulations as applicable to Kemin’s specialized crops.
• Developing and facilitating relations with key regulatory authorities and decision-makers at a country level; discussing and challenging issues and negotiating solutions in the best interests of the company.
• Acting as the primary interface between the company and local regulatory authorities on all regulatory affairs.
• Offering advice on legal and scientific restraints and requirements.
• Presenting registration documents to regulatory agencies and carrying out any subsequent negotiations to ensure that best efforts are provided to get timely approvals of dossiers for product registrations as well as relevant permits for plant material.
• Within the product innovation process, evaluating the potential use of new ingredients, giving inputs on registration requirements and timelines, giving strategic inputs on registration details to increase innovation flexibility.
• Reviewing company data before it is presented outside of Kemin for its compliance with branding guidelines and regulatory language.
• Safeguard product formulations and bill of materials on the company’s systems.
• Review and recommend changes for departmental SOP's.

• Bachelor’s degree or equivalent qualification in a scientific background.
• 3-5 years related experience. e.g., BSc Animal Science, Veterinary, Para-Veterinary or Pharmacy.

Essential skills & Experience:

• Excellent understanding of feed additives and agricultural inputs industry, research & development processes and objectives.
• Knowledge of feed regulations and requirements, and ability to evaluate impact of those regulations within the product development environment and to lead discussions of the requirements and its impacts within teams.
• Familiarity with regulations in the Sub-Sahara African region is a plus.
• Excellent attention to detail required, reliable, highly motivated, ability to work independently and interacts well in a team environment.
• Possess excellent verbal, written and interpersonal communication skills, demonstrated good technical writing skills, ability to present ideas effectively.
• Excellent organizational and time management skills, demonstrated prioritizing, planning and project management skills.
• Experience in reviewing and evaluating scientific literature with demonstrated ability to analyze and assemble/synthesize scientific information from many sources, including identification of information gaps and future research needs.

Personal characteristics:

• Ability to develop strong networks and influence internal and external stakeholders.

Professional Registration:

• Registration with either the South African Council for Natural Scientific Professions (SACNASP), South African Veterinary Council (SAVC) or South African Pharmacy Council (SAPC) is an advantage.

#LI-KK1

Do you want to be responsible for product safety and product compliance? Are you or do you want to become the Regulatory Affairs Specialist who is motivated by co-operating with all departments and interacting with external parties like customers and authorities? IGM is looking for a new global team member that fits these criteria!

This job can be done from Waalwijk, NL or from Gerenzano, Italy

You will be globally assessing the impact of new and emerging legislation. You set up and manage product registrations. If there are discrepancies in compliance you will highlight them and work to correct these. Besides the internal contacts, you will be the liaison between our organization and external consultants to ensure projects are on target and on budget.

Furthermore, you will collaborate with external specialists (for example hazard communication specialists) and you provide support to customers through questionnaires or direct questions, to suppliers, agents, and IGM team members. Presenting regulatory updates, internally and externally, is an important part of the job.

IGM Resins is recognized as the leader in UV Technology. Headquartered in Waalwijk, the Netherlands, IGM is the world’s leading manufacturer of specialty chemicals focused on the UV Inks, coatings, and adhesives market. Manufacturing and product development activities are in Europe and Asia with sales and distribution locations strategically positioned globally to best serve regional markets.

IGM Resins has grown through organic and acquisitions over the last 5 years and currently employs around 700 team members globally.

You are an independent Regulatory specialist with commercial and business insight. You are focused on quality, and you are able to organize your own work. You have well-developed communication skills in English. Travelling will be part of the role to IGM locations, customers, or authorities.

You have a Bachelor's degree in Chemistry and/or General Science, with a minimum of 5 years working experience in an international organization focusing on compliance/regulatory affairs in the UV radiation curing industry. Familiarity with GHS, international legislation, specifically product safety issues (indirect food contact, substance migration) is a much-appreciated quality.

We work with a great and energetic group of people. We value our team members, and we will offer a generic benefit package. Development and attention to people are also very important to us! We offer a dynamic and diverse working culture. You will be working in a team with a nice mix of people with different backgrounds and experience within a growing company with a clear vision.

A place where you get a lot of responsibility and possibilities for personal development!

Did you get excited? Then we could be a match! We encourage you to get in touch with us! Please send your resume to Babette van Loon , P&O manager EMEA and/or Marco Bulloni , P&O manager Italy, via .

Reference: DBN003453-SS-4
A leading pharmaceutical company has a vacancy for a Regulatory Affairs Manager.

Job Purpose:
Lead the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio and team outputs. Ensure legal compliance with the relevant medicine Regulatory Authorities (Country Specific where applicable), Medicines and Related Substances Control Act and South African Pharmacy Council, ensuring timeous processing of regulatory applications.

Key Responsibilities:

1. Manage work streams for- and report on the assigned group of portfolios
2. Assisting with internal product queries from relevant departments
3. Assisting with external product queries from the SAHPRA, other MRA’s and third-party stakeholders
4. Establish regulatory priorities and allocate resources and workloads
5. Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
6. Co-ordination and submission of new product applications in South Africa and other applicable territories, including but not limited to:
1. Develop regulatory strategies and implementation plans for the preparation and submission of new products
2. Conduct dossier due diligence to ensure all data gaps are addressed
3. Prepare the registration applications for submission to the regulatory authorities
4. Work in collaboration with NBD to assess regulator’s submissions requirements
5. Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines
6. Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
7. Internal training and mentoring
8. Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders
9. Formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced.
10. Manage activities such as internal audits or regulatory agency inspections
11. Ensure alignment of personal and company values

Requirements:

1. Bachelor’s degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
2. Minimum of 5 years’ experience in Regulatory Affairs, preferably in human medicines. Demonstrated experience across the product development, commercialization and maintenance lifecycle
3. Experience in use of CTD software builder and compilation of eCTD application will be an advantage.
4. Sound project management capabilities
5. Proven ability to consistently deliver to quality, time and cost standards Professional people management experience

Competencies:

1. Experience in use of CTD software builder and compilation of eCTD application will be an advantage.
2. IT skills
3. Leadership skills, management of personnel resources
4. Ability to prioritise and work to tight deadlines
5. Systems and operations analysis
6. Active learning
7. Strategic thinking
8. Ability to cope with a high degree of complexity and change
9. Cross Functional skills: Ability to network, liaise and negotiate with others
10. Ability to set standards and objectives and monitor progress
11. Complex problem solving and decision-making skills
12. Customer relationships
13. Development of people
14. Must demonstrate responsibility, excellence and collaboration and align with Company values

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on Should you receive no feedback within 7 days, please accept your application as unsuccessful.

Job Summary

In this high profile role, the Regulatory Affairs Specialist I will be an integral part of an expanding regulatory affairs team that is responsible for maintaining and documenting our mission critical domestic and international regulatory filings and registrations. From coordinating with international regulatory team members on product changes to maintaining up-to-date information on domestic regulatory requirements, the incumbent will be a key person in making it happen. The incumbent's medical device regulatory expertise, organizational ability, and multi-tasking skills will be rewarded with opportunities for career growth and advancement in a company that makes a difference in people's lives.

Duties & Responsibilities

• Support the regulatory team managing international and domestic filings/registrations;


• Coordinate with international regulatory team members on product changes and regulatory notification / approval requirements;


• Assist in maintaining product list on Certificate of Foreign Government;


• Maintain up-to-date knowledge on international and domestic regulatory requirements;


• Generate and maintain product compliance checklists;


• Provide regulatory support to the OEM Deployment group;


• Work with QA and Engineering in generating risk analysis, FMEA, and FTA reports;


• Submit document change orders (DRO/agile) for approvals;


• As requested by supervisor, represent RA department in project meetings and provide regulatory guidance;


• Update RA responsible quality system procedures as required (SQP/SOP's);


• Performs other duties or special projects as assigned;
  
  
  
  • Computer Proficiency with MS Office (Word/Excel/Access/Outlook);
  
  

Minimum & Preferred Qualifications and Experience

Minimum Qualifications

• Excellent verbal and written communication skills;


• Excellent prioritizing, organizational, and interpersonal skills;


• Excellent documentation skills including record maintenance/tracking and understand document traceability;


• A detail-oriented individual with a "can do" attitude;


• Ability to work in a team environment as well as individually with minimal supervision;


• Ability to work in a fast-paced , Project Team environment, with multiple tasks/projects;

Preferred Qualifications

• Some previous work experience in a medical device Class II/ III environment;


• Experience in patient monitor systems, hospital-based products, software or electronic device products;
  
  
  
  • Knowledge of regulatory submission requirements for FDA Class II medical devices, and equivalent classification requirements for international submission;
  
  
  • Experience with FDA/GMP requirements for medical device;
  
  
  • Experience in Quality Systems, per ISO 13485;
  
  


• Experience with the UL/ETL certification process;
  
  
  
  • Experience interacting with regulatory bodies, such as the Notified Body;
  
  

Education

BA/BS Degree is required, preferably in life sciences, engineering or business

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver's license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.