Quality Assurance and Regulatory Affairs Manager

About the role

A medical equipment supplier based in Johannesburg is looking for a Quality Assurance and Regulatory Affairs Manager. This is a senior appointment in a company that is growing, working on improving healthcare experiences for hospitals and medical practices. The salary is described as very negotiable.

Key responsibilities

• Quality management (ISO 9001 and ISO 13485): implement and maintain the standards, design and document quality practices, train internal ISO audit managers and run regular internal reviews.
• Risk and incident management: conduct supplier risk assessments, analyse customer surveys against quality parameters and manage incident reporting and confidentiality.
• Health and safety: act as the company Health and Safety Officer, ensure compliance across sites and branches and prepare project documentation.
• Regulatory compliance: keep registrations with regulatory bodies such as SAHPRA up to date and stay informed on local legislation and industry changes.
• Human resources: train and develop staff, monitor performance using KPIs and build relationships with divisional heads.

Required profile

• Degree or diploma in quality assurance and/or regulatory affairs management.
• 5+ years of experience in medical equipment quality assurance.
• Exposure to infection control processes.
• Familiarity with multi-company structures and African transactions.

Required skills

• Root cause analysis.
• Knowledge of health and safety regulations (OHSAS 18001).
• Understanding of ISO 14000 and waste management standards.