Quality Assurance and Regulatory Affairs Manager

Company Overview:

Join our dynamic medical equipment supplier team! We're revolutionizing healthcare by creating seamless experiences for hospitals and medical practices. Be part of our mission-driven journey!

Responsibilities:

- Quality Management (ISO 9001 & 13485):

  - Implement and maintain ISO 9001/13485 requirements.

  - Design and document quality management practices.

  - Train internal ISO audit managers.

  - Ensure compliance through regular internal reviews.

- General Business Risk:

  - Conduct Supplier Risk Assessments.

  - Analyze customer surveys against quality parameters.

  - Manage incident reporting and confidentiality.

- Health & Safety:

  - Assume the role of Company Health and Safety Officer.

  - Ensure compliance across sites and branches.

  - Prepare necessary documentation for projects.

- Regulatory Assurance & Compliance:

  - Maintain registrations with regulatory bodies (e.g., SAHPRA).

  - Stay informed about local legislation and industry changes.

- Human Resource Activities:

  - Train and develop staff.

  - Monitor performance (KPIs).

  - Foster relationships with divisional heads.

Requirements

Requirements:

- Degree or diploma in quality assurance and/or regulatory affairs management.

- 5+ years' experience in medical equipment quality assurance.

- Exposure to infection control processes.

- Familiarity with multi-company structures and African transactions.

- Root cause analysis skills.

- Knowledge of health and safety regulations (OHSAS 18001).

- Understanding of ISO 14000 and waste management standards.

Benefits

This is a senior appointment in a company that is going places.