237 Regulatory Standards jobs in South Africa
Quality Assurance and Regulatory Affairs Manager
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The Quality Assurance and Regulatory Affairs (QARA) manager will be responsible to implement manage and improve all quality and regulatory affairs related processes and the ISO13485 : 2016 complaint quality management system (QMS). The QARA manager will advise senior management on the status of the processes and QMS for compliance with international and local medical device standards and regulations.
Qualifications, Experience and SkillsRequired :
3 -5 years minimum experience in document control within a certified quality management system (QMS)
- Advance proficiency : ISO 13485 : 2016
- Candidate must possess intermediate usage skills with Microsoft Office (Outlook Excel PowerPoint etc.)
Preferable / Advantageous :
- Bachelors degree in a microbiology biochemistry or related field or engineering
- Intermediate proficiency : Medical device CE MDD and MDR
- Advanced proficiency : ISO13485 : 2016
- Advanced proficiency : SAHPRA requirements
- Intermediate proficiency : BOTSWANA (BOMRA)
- Experience in medical device manufacturing and related concepts of working in a cleanroom.
- Experience in sterilization of medical devices (EO / Gamma sterilization compliance to ISO 11135 / 11137).
- Experience in electronic device design and manufacture.
Document and process change management implementation and daily record control including maintenance of the internal document register. This comprises of the withdrawal re-issuing disposal and archiving of documents including all electronic platforms.
- Timeous recording monitoring reporting and feedback on the complaints and PCAR (CAPA) systems.
- Ensure that required regular meetings are planned and applicable reports are available in advance. This include but may not be limited to complaints QA management review etc. Minutes must be taken and shared for input from meeting attendees. The final report and minutes to be shared with all relevant persons.
- Support other team members in various projects as assigned and applicable or requiring input from quality assurance and regulatory affairs.
- Ensure customer or user training records are filed and easily referenced for audit purposes.
- Effectively implement and maintain SAHPRA FDA and other country specific applicable regulations and guideline for distributed and manufactured products.
- Actively identify possible areas of improvement and report this to top management for consideration.
- Ensure the design file for manufactured products are updated and all required notifications of change performed in compliance with all requirements.
- Act in the role of authorised representative for the Xpella company for SAHPRA.
- Act in the role of management representative for ISO : 2016 compliance.
Responsible for the review and update of the external documents register including purchasing of new standards. Initiate and perform a review and GAP analysis on new or revised external documents and implement or guide process owners in the requirements and changes to ensure compliance.
- Review monthly environmental data collected by the quality assistant to ensure any out-specification results are identified and reviewed for impact on products that is distributed from the warehouse.
Writing of the management review report include statistical analysis (available 2 weeks before scheduled meeting) meeting notes and follow-up / documentation of feedback on open actions.
- Timeous document monitoring and reporting on the non-conforming product systems including deviations and concessions during and after manufacturing runs. The quality assistant will provide all the required information.
- Participate in the internal and external audits as per the audit schedule. Ensure that relevant persons and management is aware of any audits.
- Track and follow up or record feedback on the annual quality objectives and KPIs.
- Quality system training and completion of training records.
- Perform device registration in the local and SADC markets.
- Update the current NuAngle Medical QMS system to the format of the Xpella company QMS system (process based). Update the documents with the new NuAngle logo / header (brand changes) including NuAngle updates in Xpella documents.
- Create QMS system (import and distribution) for NuAngle Solutions Aesthetics and Technologies for ISO13485 : 2016 certification purposes based on the current system and processes already in place.
- Complete required application documents and submission to SAHPRA to obtain and maintain licenses.
- Maintain and plan the companys internal quality audit program. Ensure that required non-conformances are documented and addressed in a timeous manner.
- Attend all SAMED and MDMSA Meetings and Feedback to management.
Ensure the cleanroom review is completed with the quality assistant before manufacturing commences.
- Ensure that batch record control documents are completed daily during ad-hoc the process aid the quality assistant with management of the manufacturing team if required. Also aid in manufacturing process in terms of physical device assembly quality control checks and product release. Ensure training records of manufacturing is completed with the batch record forms.
The quality assistant is responsible for monitoring the manufacturing suppliers and service providers. As the QARA manager ensure that it is being addition the control of other suppliers and service providers will be the responsibility of the QARA manager.
- Initiate and maintain a record of the QARA contractual requirements for suppliers and service providers.
- Ensure that QA agreements are in place with suppliers with regards to the specific requirements for NuAngle Group and Xpella company with regards to access to documentation and information for product registration change management and complaint / recall / communication timelines.
- Ensure purchasing specifications are updated in-line with design documentation and changes throughout the lifetime of the manufactured devices.
Maintain risk management process for the business and ensure it is updated when required.
- Recording risk assessment matrix and writing of risk management report for manufactured devices based on ISO14971.
- Update risk management file when new risks are identified through :
- Post Market-surveillance feedback
- Annual review of adverse event data bases
- Post-production information
- Post-marketing information
All marketing material must be approved after review by the Regulatory Affairs Manager for correct use of regulatory logos and information for manufactured product.
- All product labelling and IFU must be approved by the Regulatory Affairs Manager including labels printed for manufacturing runs.
- Compilation of medical device files
- Ensure regulatory conformance and requirements for the design and medical device files are met during all stages of product life cycle.
- Create and maintain medical device file contents.
- Submission of medical device file to notified body or health authorities when required.
- Perform health authorities applications in any territory the device will be sold.
- Post market surveillance clinical evaluation usability vigilance reporting and recall device marketing and registration
The QARA Manager is responsible to maintain and capture activities and documents as per the relevant procedure for each process in compliance with the country specific requirements for markets into which the manufactured product will be sold.
- Registers and records applicable to these procedures must be maintained.
The QARA Manager is responsible to create update and maintain design and development files of the manufactured product in compliance with all applicable standards.
- The QARA manager will co-ordinate the design team and ensure all required documents are created and available in the product design files.
Were on the hunt for top talent on behalf of our awesome client! If this sounds like your kind of gig hit that apply button! Only shortlisted candidates will be contacted and we keep things 100% confidential. Were all about equal opportunities hereeveryones welcome!
Key SkillsProofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills
Employment Type : Full Time
Experience : years
Vacancy : 1
#J-18808-LjbffrQuality Assurance
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To succeed in this role, you should have a bachelor’s degree in quality, chemistry, or a related field, along with proven experience in Quality Assurance within a production or manufacturing environment. A detail-oriented approach and the ability to interpret technical and regulatory data are essential.
Qualifications- Bachelor’s degree in quality, chemistry, or a related field.
- Proven experience in Quality Assurance within a production or manufacturing environment.
- Strong leadership , communication , and organisational skills.
- Detail-oriented with the ability to interpret technical and regulatory data.
To start the application process, send your CV to NDC Personnel and Contractors today: /
NotesNDC Personnel and Contractors adheres to the requirements of the POPI Act. If you do not hear from us within 14 days, please consider your application unsuccessful.
#J-18808-LjbffrQuality assurance
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Quality Assurance Director
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TP City of Cape Town, Western Cape, South Africa
The Director of Quality is responsible for leading and executing the quality strategy across a key global account within the BFSI (Banking, Financial Services, and Insurance) sector. This role will span multiple geographies (UK, South Africa, Europe, and India), ensuring consistent quality standards, regulatory compliance, and operational excellence across all delivery centers.
The ideal candidate will bring deep expertise in quality assurance methodologies, automation and financial oversight, with a strong understanding of FCA regulations and conduct risk. They will lead a high-performing team to drive continuous improvement, enhance customer experience, and deliver measurable business outcomes.
Key Responsibilities and Accountabilities Strategic Leadership- Develop and implement a global quality strategy aligned with client expectations and regulatory requirements.
- Lead cross-regional quality teams to ensure consistent execution of QA frameworks and methodologies.
- Champion a culture of operational excellence, continuous improvement, and customer-centricity.
- Ensure adherence to FCA regulations and conduct standards across all geographies.
- Implement and maintain COPC and Lean Six Sigma frameworks to drive process efficiency and error reduction.
- Establish proactive quality monitoring systems to identify risks and improvement opportunities.
- Drive adoption of QA technologies including analytics platforms, RPA, and AI to enhance quality outcomes.
- Identify and implement automation opportunities to reduce manual effort and improve accuracy.
- Leverage data intelligence to inform strategic decisions and client reporting.
- Act as a trusted advisor to clients, providing insights and recommendations during MBRs/QBRs.
- Collaborate with delivery, client services, and support functions to ensure quality commitments are met.
- Host client visits and showcase quality capabilities and innovations.
- Own the quality function’s budget, forecasts, and ROI targets.
- Provide financial insights and recommendations to improve cost efficiency and service value.
- Track and report on financial performance of quality initiatives.
- Lead, coach, and develop a global team of quality professionals.
- Foster a high-engagement, people-first culture with strong recognition and development programs.
- Ensure compliance with data protection, security, and fraud prevention policies.
- Minimum 10 years in a senior quality leadership role, preferably in BFSI.
- Proven experience managing quality across multiple geographies.
- Strong understanding of FCA regulations and conduct risk.
- Expertise in COPC standards and QA methodologies.
- Demonstrated success in implementing QA technologies and automation.
- Financial acumen with experience in budgeting, forecasting, and ROI analysis.
- Exceptional stakeholder management and communication skills.
- Expert user of Microsoft Office tools including MS Word, Powerpoint, Excel, Outlook and others
- Ability to use Excel’s advanced analytical tools such as run charts, histograms, pareto charts, scatter plots, regression, CPK, and be able to explain this to different audiences
- Director
- Full-time
- Quality Assurance and Management
- Outsourcing and Offshoring Consulting
Quality Assurance Pharmacist
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Key Responsibilities Operational efficiency
- Contribute to the creation and implementation of best practice processes and procedures to aid and improve operational performance and timely release of product to market.
- Contribute to timely implementation of QA projects.
- Conduct, manage and coordinate batch release reviews and approve final product release to the market as per the legal requirements and guidelines set by SAHPRA and the Department of Health, and in line with the registered dossier.
- Always maintain and coordinate all the GMP principles as required by SAHPRA as stipulated in the latest version of the SAHPRA / PIC / S (Pharmaceutical Inspection Co-operation Scheme) guidelines for cGMP and related systems and procedures to ensure compliance.
- Liaise and coordinate with relevant 3rd parties to ensure all pre-requisites are available to action a product release.
- SAP releasing and processing, including but not limited to batch creation and amendments.
- Ensure direct communication and continuous pursual of achieving annual plans and schedules (including but not limited to annual stability plan, annual product quality review schedule, Quality Agreement renewals, annual audit plan, departmental training plans).
- Liaise and communicate any anomalies, non‑compliances and discrepancies to the rest of the team and assist with deviations and investigations.
- Ensure accurate capture of data across all electronic platforms.
- Assist with any product related GMP activities, including but not limited to stability, annual product quality reviews, quality agreements, audits and risk assessments.
- Review of executed Batch Manufacturing documents received from 3rd parties.
- Assist in product recalls / mock recalls.
- Ensure Head office sample storage is accurately controlled and ensure S6 and SS5 registers remain balanced at all times.
- Maintain in-house documentation relating to QA processes, ensuring compliance with current SAHPRA licensing conditions for import and export functions (procedures, forms, registers, records and reports).
- Review and monitor the below but not limited to :
- Product change control process
- Issue log (Including deviations, CAPAs, change control process, Investigations)
- Destructions
- Risk Assessments
- Internal QMS documents: SOPs, forms, registers and records
- Temperature monitoring during transportation
- Perform any other duties as per changes in operational requirements of the department.
- Perform any other duties as required.
Quality Assurance Technologist
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Role: Quality Assurance Technologist
Location: Johannesburg
Salary: Market Related Salary
Responsibilities- Maintain document control and accurate record-keeping
- Implement and monitor corrective and preventive actions (CAPAs)
- Oversee audits, supplier visits, and verification testing
- Manage non-conformances and conduct root cause investigations with long-term solutions
- Drive implementation of core quality standards and manage the site quality management system
- Implement and monitor prerequisite programmes (PRPs) and act as pest control officer for the warehouse
- Ensure hygiene services and standards are consistently upheld
- Lead continuous improvement initiatives, monitor FIFO practices, and conduct sensory evaluations when needed
- Drive and improve processes to keep quality at the core
- Bachelors Degree in Food Science or related field / Advanced Diploma
- Minimum of three years experience in quality assurance and manufacturing
- Excellent communication and presentation skills
- Proficiency in Microsoft Word and Excel
- Strong planning, organisational, and execution abilities
- Results-orientated and able to perform well under pressure
- Ability to delegate tasks effectively when required
- Strong interpersonal and employee relations skills
- Self-motivated and able to work independently
- Able to monitor and comply with safety rules and regulations
- Physically able to climb stairs and move easily between processing areas
Quality Assurance Chemist
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To ensure the smooth running of the lab on a daily basis and provide an effective Quality Assurance and Quality Control service to ensure an optimised clinker/cement making process. Ensure adherence to optimized laboratory processes.
Responsibilities- Ensure smooth daily operation of the laboratory.
- Provide an effective Quality Assurance and Quality Control service to optimise clinker/cement making processes.
- Ensure adherence to optimized laboratory processes.
- Seniority level : Mid-Senior level
- Employment type : Full-time
- Job function : Research, Analyst, and Information Technology
- Industries : Building Materials
Location: Piketberg, Western Cape, South Africa
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Quality Assurance Tester
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Quality Assurance Tester role at Remote Recruitment. We are looking for a meticulous and critical-thinking AI Automation Quality Assurance (QA) Tester to ensure the reliability and accuracy of our AI-driven solutions. As a QA Tester, you will be responsible for designing and executing test cases for our automation workflows and AI models. This role requires a keen eye for detail, a strong understanding of both technical and business processes, and the ability to identify potential issues before they impact our clients.
Key Responsibilities- Develop and execute comprehensive test plans and test cases for AI automation projects.
- Perform functional, regression, and end-to-end testing of automation workflows.
- Identify, document, and track bugs and defects using a bug-tracking system.
- Work closely with developers and business analysts to understand project requirements.
- Conduct performance and load testing on automation solutions.
- Validate the accuracy and performance of integrated AI models.
- Provide clear and concise feedback to the development team to improve product quality.
- Bachelor's degree in a technical field or equivalent work experience.
- Proven experience in software quality assurance or a similar testing role.
- Familiarity with testing methodologies and QA tools (e.g., Selenium, TestRail, Jira).
- A solid understanding of the software development lifecycle.
- Excellent attention to detail and strong analytical skills.
- Ability to work effectively in a collaborative team environment.
- Knowledge of AI, machine learning, or RPA is a significant advantage.
- Mid-Senior level
- Part-time
- Information Technology
- Staffing and Recruiting
Quality Assurance Pharmacist
Posted 1 day ago
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Join to apply for the Quality Assurance Pharmacist role at Pharma Dynamics (Pty) Ltd .
Responsibilities- Contribute to the creation and implementation of best practice processes and procedures to aid and improve operational performance and timeous release of product to market.
- Contribute to timeous implementation of QA projects.
- Conduct, manage and coordinate batch release reviews and approve final product release to the market as per the legal requirements and guidelines set by SAHPRA and the Department of Health, and in line with the registered dossier.
- Always maintain and coordinate all the GMP principles as required by the SAHPRA as stipulated in the latest version of the SAHPRA / PIC/S (Pharmaceutical Inspection Co-operation Scheme) guidelines for cGMP and related systems and procedures to ensure compliance.
- Liaise and coordinate with relevant 3rd parties to ensure all pre-requisites are available to action a product release.
- SAP releasing and processing, including but not limited to batch creation and amendments.
- Ensure direct communication and continuous pursual of achieving annual plans and schedules (including but not limited to annual stability plan, annual product quality review schedule, Quality Agreement renewals, annual audit plan, departmental training plans).
- Liaise and communicate any anomalies, non – compliances and discrepancies to the rest of the team and assist with deviations and investigations.
- Ensure accurate capture of data across all electronic platforms.
- Assist with any product related GMP activities, including but not limited to stability, annual product quality reviews, quality agreements, audits and risk assessments.
- Review of executed Batch Manufacturing documents received from 3rd parties.
- Assist in product recalls/mock recalls.
- Ensure Head office sample storage is accurately controlled and ensure S6 and SS5 registers remain balanced at all times.
- Maintain in-house documentation relating to QA processes, ensuring compliance with current SAHPRA licensing conditions for import and export functions (procedures, forms, registers, records and reports).
- Review and monitor the below but not limited to:
- Product change control process
- Issue log (Including deviations, CAPAs, change control process, Investigations)
- Destructions
- Risk Assessments
- Internal QMS documents: SOPs, forms, registers and records
- Temperature monitoring during transportation.
- Perform any other duties as per changes in operational requirements of the department.
- Perform any other duties as required.
- Entry level
- Full-time
- Health Care Provider
- Pharmaceutical Manufacturing
Quality Assurance Specialist
Posted 1 day ago
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Job title : Quality Assurance Specialist
Job Location : Gauteng, Johannesburg
Deadline : September 05, 2025
Responsibilities- Assist operations in tracking, documenting, and reporting on quality levels
- Analyse and investigate calls to ensure resolution in accordance with company guidelines and external regulatory requirements
- Develop or update company procedures to ensure capture, investigation, and proper documentation of complaints
- Monitor risk-management procedures, and maintain problem logs for identifying and reporting issues to management and product development
- Provide training and support to quality assurance team that includes systems, policies, procedures, and core processes
- Interpret, build upon, and comply with company quality assurance standards
- Carefully maintain complaint and nonconformance processing through records and tracking systems, including root cause and corrective actions
- Document quality assurance activities with internal reporting and audits
- Participate in the design of the call monitoring framework, quality standards and the associated checklists
- Conduct audits ensuring compliance with performance standards and outcomes (e.g. quality, compliance of process and accuracy)
- Create reports on performance results (individual and team level) to provide to management for the development and action plans for agents
- Prepare and analyse quality reports for management staff review
- Provide feedback and input into enhancements of processes, training and systems based on trends
- If required, assist with the coaching of agents based on findings
- If required, may answer phone calls, respond to written inquiries, and handle “escalated” issues in support of work performed by agent
- Work collaboratively – Build a culture of respect and understanding across the organisation; Recognise outcomes which resulted from effective collaboration between teams; Build cooperation and overcome barriers to information sharing, communication, and collaboration across the organisation; Facilitate opportunities to engage and collaborate with internal and external stakeholders to develop joint solutions
- Self-Management – Follow through to ensure that personal quality and productivity standards are consistently and accurately maintained; Demonstrate consistent application of internal procedures; Plan and prioritise, demonstrating abilities to manage competing demands; Demonstrate abilities to anticipate and manage change; Demonstrate flexibility in balancing achievement of own objectives with abilities to understand and respond to organizational needs
- Grade 12 with English and a second language
- Relevant qualification will be advantageous
- 1 – 2 years’ experience in a Quality Assurance environment or Call Centre Sales environment preferred
- FAIS Regulatory examination for Representatives (RE5) and (RE1) for Key Individual
- Administrative / Management jobs