Job Description
About the Role
We are seeking a highly experienced Regulatory, Compliance, and Health & Safety Officer to join our team in Cape Town City Centre. The successful candidate will be responsible for ensuring compliance with applicable medical device regulations and maintaining regulatory files, while also developing and implementing occupational health and safety programs.
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
- Bachelor’s degree in Regulatory Affairs, Quality Management, Life Sciences, Engineering, or related field
- 35 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.)
Qualifications
- Formal education/certifications not specified
Salary & Benefits
- Salary range not specified
How to Apply
Click the green “Go Apply” button below to apply directly online with the employer.
About Scientific / QA Jobs in Cape Town Region
The Cape Town region is home to a thriving scientific and QA (Quality Assurance) community, with many organizations across various industries seeking skilled professionals to drive innovation and quality control.
Typically, salaries for scientific and QA roles in the Cape Town region vary widely depending on factors such as experience, company size, and industry sector. Generally, entry-level positions may command salary ranges between R300 000 to R500 000 per annum, while senior roles can offer more substantial packages, often ranging from R600 000 to R1 200 000 or more, with variations based on individual circumstances.
Common skills required for scientific and QA roles include a strong foundation in mathematics and science, programming languages such as Python, Java, or C++, data analysis and interpretation, attention to detail, effective communication, and the ability to work collaboratively as part of a team. Additionally, many organizations in this sector place a high value on analytical thinking, problem-solving skills, and adaptability.
The Cape Town region is home to various industries that commonly employ scientific and QA professionals, including the technology industry, financial services sector, manufacturing sector, and research institutions. While these sectors may have varying requirements, many organizations in these areas seek skilled professionals to drive innovation, quality control, and data-driven decision-making.
For those seeking a career in scientific or QA roles, there are numerous opportunities for professional growth and development. Typically, professionals in this field can expect to move into senior roles with increased responsibility within 5-10 years of experience. Many organizations also offer training and development programs, mentorship opportunities, and networking events to support the ongoing education and skills enhancement of their employees.
As a job seeker, it is essential to research the specific requirements of various industries and companies to determine which role best aligns with your skills, interests, and career goals. By understanding the general trends in the scientific and QA job market, you can position yourself for success in this rewarding field.
This information provides general career guidance. Actual salaries and requirements vary by employer.
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