SUMMARY:
We are seeking a detail-oriented Quality Assurance & Regulatory Affairs (QA & RA) Officer to manage our Quality Management System (QMS) & ensure compliance for both medical devices & medicinal products. This role focuses on alignment with ISO 13485:2016 & SAHPRA regulations.

POSITION INFO:

Job Advertisement: QA & RA Officer

We are seeking a detail-oriented Quality Assurance & Regulatory Affairs (QA & RA) Officer to manage our Quality Management System (QMS) and ensure compliance for both medical devices and medicinal products. This role focuses on alignment with ISO 13485:2016 and SAHPRA regulations.

Key Responsibilities

• Regulatory Affairs (SAHPRA Focus): Compile, submit, and track documentation for product registrations, amendments, and renewals for both medicines and medical devices.
• Maintain establishment licenses and ensure compliant packaging/labeling.

• QMS Management (ISO 13485): Implement, maintain, and improve the Quality Management System. Manage document control (SOPs, work instructions, technical/risk files), CAPAs, non-conformances, and deviations.
• Audits & Post-Market Surveillance: Conduct internal quality audits and support external SAHPRA/ISO inspections. Monitor post-market surveillance data, trend reporting, and adverse event submissions.
• Cross-Functional Collaboration: Provide quality and regulatory guidance to manufacturing, R&D, marketing, and supply chain teams to support compliant product lifecycles.

• Bachelor''s Degree in Life Sciences, Pharmacy, Biomedical Engineering, or equivalent.
• Minimum 3 years of experience in Regulatory Affairs and/or Quality Assurance within the medical device or pharmaceutical industry.
• Certified ISO 13485 Internal Auditor.
• Strong knowledge of SAHPRA regulations, product registration pathways, and risk management (ISO 14971).