Senior Regulatory Affairs Specialist

Austin Fraser Limited
£40k - £50k pa + Bonus + Pension + Healthcare
11 Mar 2017
10 Apr 2017
Contract Type
Full Time
Austin Fraser are currently recruiting a Senior Regulatory Affairs Specialist to join a world leading Medical Devices firm based in the North West of the UK. This is a fantastic opportunity to work with a leading device manufacturer, joining the business during an exciting time of both market growth and product range/portfolio expansion.

As Senior Regulatory Specialist, you would be coming into a Regulatory team of 5 (part of a larger RA division numbering 14 in total), focused specifically on pre-market submissions. The scope of the role will include the creation and development of regulatory documentation, preparation of pre-marketing documentation (CE marking, 510(k)) and both relationship management and negotiation with regulatory bodies concerning existing and new products alike.

The core skills the client are looking for includes a minimum of 5 years Medical Devices experience, an established track record within Regulatory Affairs and in particular, experience working in compliance with the Medical Devices Directive. US (FDA) experience is not essential - though is highly desirable - and additionally, there is no specific class type experience required. As such, this role presents a fantastic chance for somebody looking for an opportunity to further their device type exposure, as the client's product range spans classes I to III.

This is excellent opportunity that, in time, will offer the chance to progress into a management position. As a Senior within the team, you will be expected to provide guidance to those with less experience, taking on a mentoring role and helping to impart, establish and ingrain best practice.

If this position is of interest, please submit your CV in response. Alternatively, if you would like to discuss the position in any more detail, please get in contact using the details provided.