Regulatory Affairs Officer

Title:
Regulatory Affairs Officer
The information below covers the role requirements, expected candidate experience, and accompanying qualifications.
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