Quality Control Administrator (Medical) - Staff Solutions
Cape Town 15 hours ago Permanent Salary - Market Related
Quality Control Administrator (Medical)
Staff Solutions
Cape Town
Date Created : 15 hours ago
Job Type : Permanent
Salary : Market Related
Regulatory Affairs
- Ensure compliance with applicable medical device regulations (e.g., SAHPRA, FDA, EU MDR, ISO 13485, ISO 14971).
- Prepare, submit, and maintain product registrations, licenses, and approvals with regulatory authorities.
- Monitor regulatory changes and advise management on potential impact to business and products.
- Support audits and inspections by regulatory authorities and notified bodies.
- Maintain technical documentation, regulatory files, and product labeling compliance.
- Develop, implement, and monitor compliance programs in line with company policies, codes of conduct, and industry standards.
- Conduct compliance risk assessments and recommend corrective actions.
- Ensure adherence to anti-bribery, anti-corruption, data privacy, and ethical marketing practices.
- Train staff on compliance policies, procedures, and ethical conduct.
- Investigate and report compliance breaches, ensuring timely resolution.
- Develop and implement occupational health and safety programs aligned with local legislation (e.g., Occupational Health and Safety Act, ISO 45001).
- Conduct risk assessments, safety inspections, and incident investigations.
- Provide safety training and promote a culture of health, safety, and environmental awareness.
- Ensure safe handling, storage, and disposal of medical and hazardous materials.
- Maintain emergency response and business continuity plans.
Qualifications & Experience
- Bachelor’s degree in Regulatory Affairs, Quality Management, Life Sciences, Engineering, or related field.
- 3–5 years’ experience in regulatory, compliance, or HSE role within the medical device, pharmaceutical, or healthcare industry.
- Strong knowledge of medical device regulations and standards (ISO 13485, ISO 14971, EU MDR, FDA, SAHPRA, etc.).
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