Regulatory Affairs Specialist
4 weeks ago
**Job Title:** Regulatory Specialist
At Seven Life Sciences, we are seeking a highly skilled Regulatory Specialist to join our Quality and Regulatory team. The successful candidate will be responsible for maintaining compliance with ISO 13485, Medical Device Directive 93/42/EEC, and Regulation (EU) 2017/745 (EU MDR).
**Key Responsibilities:**
- Review, update, and create technical files, and conduct Post Market Surveillance activities for various medical devices.
- Address internal and external regulatory inquiries.
- Conduct internal audits.
- Support the Regulatory Manager and Quality and Regulatory Consultant.
**Working Hours:**
Monday – Friday (9am – 5pm) (37.5 hours)
**Required Experience and Skills:**
- 2 to 5 years of experience in Regulatory Affairs within the medical devices sector, preferably in a commercial setting.
- Strong knowledge of MDD and MDR.
- Proficiency in ISO 13485.
- Analytical and problem-solving abilities.
- Excellent written and oral communication skills with high attention to detail.
- Ability to multitask and prioritize effectively.
- Integrity and a professional approach to work.
- A technical background is advantageous.
**Desired Experience:**
- Writing post market surveillance reports.
- Reviewing periodic factors.
- Creating technical files.
- Clinical evaluations.
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