Manufacturing - Manufacturing Production Cape Town FULL TIME Job Summary 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. 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 & 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.). Staff Solutions Recruiter