RA Specialist

Location: Cambridge  |  Cambridgeshire  |  England
Sector: Life Sciences
Consultant: Chris Hutchinson
Job Reference: HQCHRS
Salary: £40000 - £60000
Job Status: Permanent / Full Time

I am currently looking for a RA Specialist in Cambridge (Perm)

Essential Job Duties:

Assisting with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products

Preparing document packages for regulatory submissions

Keeping abreast of regulatory procedures and changes

Reviewing proposed product changes for impact on their regulatory status

Communicating with regulatory and governmental agencies

Reviewing proposed labelling, promotion and advertising material for its compliance with applicable global regulations

Responding to requests from foreign government and/or distributors as needed.

REQUIRED COMPETENCIES

Naturally you’ll have a thorough & sound working knowledge of regulatory compliance in Europe, USA, China and Japan, and a track record of successfully gaining regulatory approvals in various markets.

3- 4 Years experience in the medical device industry

A strong attention to detail and the ability to multi-task and balance competing priorities

The ability to build relationships between Regulatory Affairs and other areas of the organization and to communicate effectively at all levels

A demonstrable hands-on approach to regulatory affairs, not being afraid to get involved with real issues.

In terms of education, we’d like you to have a Degree or higher in a relevant life science, scientific or engineering-based discipline, but a combination of education and experience may be considered.

They are offer a competitive salary from £50,000 up to £60,000 depending experience and a great benefits package (including pension, cycle-to-work scheme, life assurance, and medical insurance – as well as our now famous monthly company BBQs).

On top of that, you’ll be joining a company with a fabulous culture of ambition, creativity and teamwork, and where fun is just as valued as their commitment is to make surgery better for millions of people.

If you are interested in this please get in touch and send your CV, we are looking to interview candidates as soon as possible.