Quality Specialist (Medical)

Key Responsibilities
Regulatory Affairs:

• Ensure compliance with applicable medical device regulations (e.g., SAHPRA, FDA, EU MDR, ISO 13485, ISO 14971).
• Prepare, submit, and maintain product registrations, licenses, and approvals with regulatory authorities.
• Monitor regulatory changes and advise management on potential impact to business and products.
• Support audits and inspections by regulatory authorities and notified bodies.
• Maintain technical documentation, regulatory files, and product labelling compliance.

Product registration:

• Manage the end-to-end registration of new and existing medical devices with SAHPRA and other applicable regulatory authorities.
• Compile, review, and submit complete product registration dossiers, including technical, clinical, quality, labelling, and administrative documentation.
• Coordinate product registration renewals, amendments, variations, and change notifications within prescribed timelines.
• Liaise with regulatory authorities, manufacturers, suppliers, and authorised representatives to resolve registration queries and obtain outstanding information.
• Maintain an accurate product registration database, submission tracker, approval records, certificates, licenses, and supporting documentation.
• Assess product, manufacturing, supplier, and labelling changes to determine their regulatory impact and required submissions.
• Monitor registration timelines and provide regular status updates, risks, and escalation reports to management and relevant stakeholders.
• Work cross-functionally with Quality, Sales, Marketing, Supply Chain, and international regulatory teams to support compliant product launches and continued market access.
• Manage the annual price increase process for registered products across the various funders, including preparing and submitting pricing schedules and supporting documentation, monitoring approvals, responding to queries, and maintaining accurate pricing records.

Quality Control:

• Develop, implement, and maintain quality control procedures in accordance with company requirements, ISO 13485, and applicable medical device regulations.
• Perform or coordinate incoming, in-process, and final product inspections to confirm compliance with approved specifications and quality standards.
• Review product documentation, certificates of analysis or conformity, labelling, packaging, and release records before distribution.
• Manage non-conforming products, deviations, complaints, and corrective and preventive actions, ensuring timely investigation, documentation, and closure.
• Monitor quality trends and key performance indicators, identify recurring issues, and recommend process or product improvements.
• Maintain accurate inspection, testing, calibration, traceability, and product-release records.
• Coordinate with suppliers, manufacturers, Operations, Regulatory Affairs, and other relevant teams to resolve quality issues and safeguard product integrity.
• Support internal and external quality audits and ensure identified findings are addressed within agreed timelines.

Compliance:

• Develop, implement, and monitor compliance programs in line with company policies, codes of conduct, and industry standards.
• Conduct compliance risk assessments and recommend corrective actions.
• Ensure adherence to anti-bribery, anti-corruption, data privacy, and ethical marketing practices.
• Train staff on compliance policies, procedures, and ethical conduct.
• Investigate and report compliance breaches, ensuring timely resolution.

Health & Safety (HSE):

• Develop and implement occupational health and safety programs aligned with local legislation (e.g., Occupational Health and Safety Act, ISO 45001).
• Conduct risk assessments, safety inspections, and incident investigations.
• Provide safety training and promote a culture of health, safety, and environmental awareness.
• Ensure safe handling, storage, and disposal of medical and hazardous materials.
• Maintain emergency response and business continuity plans.

Qualifications & Experience:

• Bachelors degree in Regulatory Affairs, Quality Management, Life Sciences, Engineering, or related field.
• 35 years experience in regulatory, compliance, or HSE role within the medical device, pharmaceutical, or healthcare industry.
• Strong knowledge of medical device regulations and standards (ISO 13485, ISO 14971, EU MDR, FDA, SAHPRA, etc.).