Senior Regulatory Affairs (Medical devices)

45000.00 - 65000.00 GBP Annual + GBP45000 - GBP65000/annum
25 Aug 2017
23 Sep 2017
Contract Type
Full Time
My client, a medical device company based in Yorkshire and is at the leading edge of technology and has won many awards for innovation. They are currently recruiting for a Senior Regulatory affairs specialist to lead all aspects of successful regulatory documentation and submission. The Regulatory affairs specialist will be responsible for maintaining and ensuring that the dossiers meet the regulatory body requirements for new products from Design to customer complaints.

Regulatory affairs specialist Responsibilities:
- Own the process of compiling and completing dossiers for Class III devices
- develop relationship within the company to ensure data/evidence is available at the right time of submission
- Develop, manage and maintain the company device family - technical files, product specific design dossiers and compliance
- Keep up to date with changes in regulatory legislation within all countries
- Liaise with notified bodies and over see international submissions
- Input to compliance and QMS across the site and develop the world class product

Essential and personal Experience
- Must have previous experience of dossier submission ideally within Class III, IIb, IIa
- Ability to build and work within a team, Liaise with notified bodies
- An aptitude for the critical assessment of scientific reports and protocols.
-Degree qualified - preferably Engineering or Scientific
-Circa a minimum of five years of RA related professional experience, ideally within Class III, IIa,and IIb medical devices
-Proven ability of successfully completed acceptance of Regulatory dossiers by notified bodies

If you believe you hold the relevant background experience and looking for a fantastic opportunity to join a growing Medical device company and in return they are offering a competitive package, fantastic benefits
The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK and on this occasion TemplarFox Consultancy is acting as an employment agency