Regulatory Affairs Officer - Edinburgh, United Kingdom - Cpl Life Sciences

Description

Job Title:

Regulatory Affairs Officer Location:
Near Edinburgh, Scotland, UK - 3 days on site per week.
Attractive salary and package (Relocation support can be considered)

An exciting opportunity to join an established and growing IVD manufacturer and support a growing Regulatory Affairs Department.

In this role as a Regulatory Affairs Officer, you will be responsible for supporting new registrations, reviewing, updating technical files and supporting the Swiss side of the organsiation with NPD.

The ideal candidate will have a strong scientific background with around 1 years of experience dedicated in RA.

The position will also collaborate cross functionally to build regulatory strategy, determining applicable regulatory requirements, proposing solutions to comply with regulatory requirements, and managing product license registration with the appropriate regulatory authorities worldwide.

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.

Leading and coordinating the vigilance process in interface with the complaint handling process.

Providing support to the Department Leader of Regulatory Affairs with regard to planning and co-ordination of activities and with regard to training and supervision of other members of the Regulatory Affairs team and to ensure continuous development of junior staff to develop their capabilities.

Developing product labelling regulatory requirements for products and for customer-contracted products including but not limited to package labels, product labels, and instructions for use.

A relevant degree and/or relevant work experience in a regulatory affairs environment.
Experience in a medical device / IVD / biotech industry
A strong scientific background with 6-12 months experience in RA.