Regulatory Affairs Specialist

Intech Recruitment.
£40000 - £45000 per annum + pension and extensive benefits
16 Oct 2016
15 Nov 2016
Contract Type
Salary: £40,000-45,000
Benefits: Comprehensive range of corporate benefits.
Type: Permanent
Location: Wiltshire

As the Senior Regulatory Affairs Specialist you will enjoy a broad remit working on new product introduction and change management. You will act as the regulatory interface throughout the product realisation process and during the entire product life cycle including post-market surveillance.

The role will cover: class III design dossiers, preparation of technical files for class I, IIa, IIb (EU), Premarket Approval Applications (PMAs) and Premarket Notifications (510(k)s).

Senior Regulatory Affairs Specialist Responsibilities:
* Sit on design review teams and provide interactive feedback and assist in the development of supporting documentation.
* Develop Regulatory strategy for projects.
* Assist in the development and implementation of the post-market surveillance.
* Develop documents to submit to Notified Bodies and FDA:

Essential experience and qualifications
* Requires the ability to work with a variety of levels and stakeholders within and outside of the business.
* Working knowledge of FDA and MDD regulations.
* Strong knowledge and experience of class III devices.
* Bachelor's or higher degree in a scientific or clinical degree is extremely desirable.
* Two years experience of regulatory affairs within the medical device industry is desired.

For more information and to apply for this position, please send your CV with a covering email to explain why you feel you should be considered for this post.
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