Regulatory Affairs Specialist

Key Responsibilities 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. Qualifications and Experience 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 Skills and Competencies 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.

Location: Stellenbosch, ZA

Posted Date: 6/15/2025