Quality Assurance And Regulatory Affairs Manager

Johannesburg, Gauteng, South Africa

Job Description

:
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!

Skills Required

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Job Detail

  • Job Id
    JD1564855
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Johannesburg, Gauteng, South Africa
  • Education
    Not mentioned