Regulatory Affairs Specialist

• Drive interdepartmental preparation for regulatory submissions.
• Maintain up-to-date knowledge of applicable regulatory requirements.
• Support internal and external audits.
• Provide regulatory input for product development and the full product lifecycle.
• Maintain regulatory files and documentation.
• Support post-market surveillance and vigilance reporting.

• A tertiary qualification in a science, engineering or biological field is essential.
• Minimum of 3 years experience in the medical device industry.
• Proven experience with any of the following will be advantageous:
• ISO 13485 Quality Management System
• EU MDR 2017/745 Technical Documentation and conformity assessment
• FDA 510(k) submissions and US FDA requirements

• Excellent organisational and project management skills
• Task driven
• Detail-oriented with strong analytical and problem-solving abilities
• Clear and effective verbal and written communication skills
• Ability to work independently and in cross-functional teams

NOTE: We ONLY accept online applications. We do not consider direct applications via Whatsapp or email.

The proposed salary bracket for the position is R30k - R40k, but note that the employer retains the right to provide a remuneration package that aligns with industry norms and the specific qualifications, skills and experience of the selected candidate.