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.RequirementsRequirements:- 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.BenefitsThis 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!

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Job Detail

  • Job Id
    JD1333655
  • 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