Job Description
Key Responsibilities
Regulatory Affairs
Compliance
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....