Quality Assurance and Regulatory Affairs Manager

Company Overview:

Join our dynamic medical equipment supplier team! Were revolutionizing healthcare by creating seamless experiences for hospitals and medical practices. Be part of our missiondriven 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 multicompany 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.