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
For more information regarding this position or any others, please call Aoife on 07825140518

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.