Regulatory, Compliance, and Health & Safety Officer

SUMMARY:
Our client, in the manufacturing/medical industry, based in Brackenfell, Cape Town, is looking to appoint a Regulatory, Compliance, and Health & Safety Officer.
The Regulatory, Compliance, and Health & Safety Officer is responsible for ensuring that the company’s medical technology products, operations, and workplace practices comply with local and international regulations, industry standards, and internal policies. This role safeguards product quality, patient and user safety, and employee well-being while minimizing corporate risk

POSITION INFO:
Key Responsibilities
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.

• 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.).