Job Description
About the Role
The Regulatory, Compliance, and Health & Safety Officer will play a crucial role in ensuring the company’s medical devices comply with relevant regulations and industry standards. This position requires strong knowledge of regulatory affairs, compliance programs, and health and safety practices.
Key Responsibilities
- 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.
Requirements
- Strong knowledge of medical device regulations and standards (ISO 13485, ISO 14971, EU MDR, FDA, SAHPRA, etc.).
- 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.
Qualifications
No formal education or certifications are required for this position.
Salary & Benefits
Salary details are not specified in the original job description.
How to Apply
Click the green “Go Apply” button below to apply directly online with the employer.
About Manufacturing Production Jobs in Western Cape
In Western Cape, South Africa, the manufacturing production sector is generally thriving, driven by a growing demand for goods and services from local and international markets. The industry is often characterized by its fast-paced and dynamic environment, requiring skilled professionals to oversee the production process and ensure efficiency.
Typically, manufacturing production positions in Western Cape offer competitive salaries, generally ranging between R400 000 to R800 000 per annum, depending on factors such as experience, company size, and industry sector. However, it is essential to note that actual salaries can vary widely, and this range is only a general guideline. Experience, qualifications, and specific job requirements also play a significant role in determining salary expectations.
Common skills required for manufacturing production roles in Western Cape include technical knowledge of manufacturing processes, problem-solving abilities, attention to detail, communication skills, teamwork experience, and adaptability to new technologies and systems. Typically, candidates with a strong understanding of quality control, supply chain management, and production planning are also in high demand.
Manufacturing production positions can be found across various industry sectors, including the technology industry, manufacturing sector, and other industries that rely on production processes. Commonly, these roles are filled by professionals with experience in factory operations, quality assurance, or production management.
Career development opportunities for manufacturing production professionals in Western Cape are plentiful, with many companies investing in training and development programs to enhance skills and knowledge. Typically, career progression paths may include moving into supervisory or managerial roles, taking on specialist responsibilities, or transitioning into related fields such as project management or supply chain coordination. With experience and continuous learning, professionals in manufacturing production can look forward to a range of career advancement opportunities.
This information provides general career guidance. Actual salaries and requirements vary by employer.
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