Regulatory Affairs Officer

2 days ago


City of Edinburgh, United Kingdom Cpl Life Sciences Full time

Job Description Job Title: Regulatory Affairs Officer Job Type: Full-time, permanent position Location: Outskirts of Edinburgh, Scotland, UK – 3x a week on site.
Remuneration: £35,000 to £40,000 + benefits An exciting opportunity to join an established and growing IVD manufacturer and support a growing Regulatory Affairs Department.
Responsible for managing product license registration with the appropriate regulatory authorities on a worldwide basis.
This includes the preparation of any regulatory dossiers and/or supporting documentation.
In addition, the department will manage the maintenance of such registrations/licences once granted.
: Main responsibilities: Preparing and compiling regulatory documentation, coordinating and executing regulatory submissions in compliance with ISO13485, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Biologics License Applications (BLA), Medical Device Approvals (510(k)), Canadian Medical Device Regulations (CMDR) – Part 1 and other country requirements as appropriate.



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