Regulatory Compliance and Health & Safety Officer

Exceed Human Resource Consultants; Wes-Kaap; On-site; ZAR 200 000 - 300 000; Full time

Job summary

A leading recruitment firm is seeking a Regulatory Affairs and Compliance Specialist based in South Africa (Wes-Kaap). The ideal candidate will have 3-5 years of experience in regulatory, compliance, or HSE roles within the medical device or healthcare industry. Responsibilities include ensuring compliance with health regulations, managing product registrations, and developing health and safety programs. Interested candidates should email their CV to [e-mail].

Qualifications

• 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.

Responsibilities

• Ensure compliance with applicable medical device regulations.
• Prepare and maintain product registrations with regulatory authorities.
• Develop and monitor compliance programs.
• Develop and implement health and safety programs.

Skills

Regulatory compliance

Risk assessment

Safety training

Knowledge of ISO 13485

Job description

Reference: 10813 MLR
Consultant: Michellele Roux

Job Description

• 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.

Qualifications

• 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.).

How to Apply

• Email your comprehensive CV to [e-mail].
• If you are already registered, please forward your CV and the relevant reference number to the consultant with whom you are currently registered in order to avoid duplicity on our system.
• We reserve the right to only conduct interviews with candidates of choice.
• Applicants who have not received feedback within 30 days from the closing date must please accept their application as unsuccessful.