Regulatory Affairs Officer
3 weeks ago
Title: Regulatory Affairs Officer
Location: Edinburgh area – hybrid working
Type: Full-time, Permanent, 37.5 hours per week.
Salary: up to £37,000 DOE
SRG is working with a leading Biotechnology company based in the Edinburgh area who are looking for a Regulatory affairs officer to join their team on a permanent basis.
The regulatory affairs officer will be involved in building a regulatory strategy, determining applicable regulatory requirements, proposing solutions to comply with regulatory requirements and managing product license registration with the appropriate regulatory authorities worldwide.
Requirements:
- Scientific degree
- Previous regulatory experience within Medical Devices / IVD
- Experience of working within an FDA licensed manufacturing facility.
- Knowledge and practical experience of CE and FDA regulations, including the preparation of PMA, BLA, 510k, CE Mark and technical file submissions.
- Change control experience
Benefits:
- Private Medical cover
- Life assurance
- Additional annual leave
- Cycle to work scheme + more.
If you would like to apply for this position, please use the link provided. Alternatively please email a copy of your CV
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