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.

Join us in shaping healthcare excellence! Apply now and make a difference.

Salary very negotiable!