Regulatory Affairs Specialist
Regulatory Affairs Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- 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 thefull product lifecycle.
- Maintain regulatory files and documentation.
- Support post-market surveillance and vigilance reporting.
- A tertiary qualification in a science engineering or biological field isessential.
- 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
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.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
