Regulatory Affairs Specialist
4 weeks ago
**Job Title:** Regulatory Affairs Specialist
**Job Type:** Full-time
**Location:** Flexible
**Remuneration:** Competitive salary + benefits
The Regulatory Affairs Specialist will be responsible for implementing and maintaining regulatory compliance processes, including regulatory evaluation of non-conformances, post-market surveillance, vigilance, and associated reporting. The role will also involve coordinating HHE activities and liaising with regulatory authorities and external contract bodies.
**Key Responsibilities:**
- Be the main contact for regulatory compliance issues
- Provide PMS documentation according to IVDR requirements
- Lead and coordinate the vigilance process
- Liaise with regulatory authorities and external contract bodies
- Interface with Competent Authorities for reporting incidents and field safety actions
**Requirements:**
- A degree or equivalent in life sciences
- 1-4 years of experience in a regulatory/quality role
- Experience in the medical device / IVD / biotech industry
- Experienced in meeting with, making presentations to, and negotiating with regulators
**About Cpl Life Sciences:**
Cpl Life Sciences is a leading provider of recruitment services to the life sciences industry. We are committed to helping our clients find the best talent to drive their business forward.
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