Regulatory Affairs Specialist
4 weeks ago
Job Title: Regulatory Affairs Specialist
Job Summary:
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Seven Life Sciences. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements for medical devices.
Key Responsibilities:
- Review and update technical files for medical devices.
- Conduct post-market surveillance activities.
- Address internal and external regulatory inquiries.
- Conduct internal audits.
Requirements:
- 2-5 years of experience in Regulatory Affairs within the medical devices sector.
- Strong knowledge of MDD and MDR.
- Proficiency in ISO 13485.
- Analytical and problem-solving abilities.
- Excellent written and oral communication skills.
Desired Skills:
- Writing post-market surveillance reports.
- Reviewing technical files.
- Clinical evaluations.
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