Regulatory Affairs Specialist

Key ResponsibilitiesDrive 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 ExperienceA 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 SystemEU MDR 2017/745 Technical Documentation and conformity assessmentFDA 510(k) submissions and US FDA requirementsSkills and CompetenciesExcellent organisational and project management skillsTask drivenDetail-oriented with strong analytical and problem-solving abilitiesClear and effective verbal and written communication skillsAbility to work independently and in cross-functional teamsNOTE: 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.