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Regulatory Affairs Officer

4 months ago

Edinburgh, United Kingdom SRG Full time
Title:

Regulatory Affairs OfficernLocation:

Edinburgh area – hybrid workingnType:

Full-time, Permanent, 37.5 hours per week.nSalary : 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.nThe 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:nScientific degreenPrevious regulatory experience within Medical Devices / IVDnExperience of working within an FDA licensed manufacturing facility.nKnowledge and practical experience of CE and FDA regulations, including the preparation of PMA, BLA, 510k, CE Mark and technical file submissions.nChange control experience

Benefits:nPrivate Medical covernLife assurancenAdditional annual leavenCycle 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