Quality Assurance and Regulatory Affairs Manager
Summary
Quality Assurance and Regulatory Affairs Manager at a medical equipment supplier in Johannesburg. Day to day: implement and maintain ISO 9001/13485 quality management, run supplier risk assessments and incident reporting, act as Company Health & Safety Officer, keep SAHPRA and other regulatory registrations current, and train/monitor staff.
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.