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Regulatory Compliance Health & Safety Officer
Job summary
A leading recruitment firm is seeking a Fundraising System & Data Specialist to ensure compliance with medical device regulations and implement health and safety programs. Key responsibilities include preparing product registrations, conducting compliance risk assessments, and training staff on ethical conduct. The ideal candidate has 3-5 years of experience in regulatory affairs or compliance within the healthcare industry. Located in Brackenfell, Cape Town, this role offers an opportunity to positively impact safety and compliance standards.
Qualifications
- 3–5 years’ experience in regulatory, compliance, or HSE roles.
- Strong knowledge of medical device regulations and standards.
Responsibilities
- Ensure compliance with medical device regulations.
- Develop and monitor compliance programs.
- Conduct risk assessments and safety inspections.
Skills
Duties and 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.
- 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.
- Health & Safety (HSE)
- 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.
Requirements:
- 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.).
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.