Regulatory Affairs Team Leader

Industry Sector Biotechnology
Profession QA & Regulatory
Location UK, South East
Salary Competitive


Regulatory Affairs Team Leader (12 month FTC)

Location: Bedfordshire

Sector: Medical Devices/Diagnostics

Our client is a UK based company specialising in the branded consumer In-Vitro diagnostic products. The company is now looking for a Regulatory Affairs Team Leader to join the company on a 12 month fixed term contract to support with regulatory compliance of diagnostics products throughout the product life-cycle.

The role:

As the Regulatory Affairs Team Leader you will be responsible for:

·         Ensuring regulatory compliance of in vitro diagnostic products and medical devices.

·         Monitoring regulatory changes and implementing training on changing issues along with analysis of impact of regulatory changes on new and existing products

·         Support with regulatory submission for new products within US/EU and Canada

·         Support project teams in the understanding of regulatory demands and costings for new projects.

·         Provide guidance on regulatory strategy and planning

Experience expectations:

Suitable applicants will have;

·         Previous experience in a regulatory role within in vitro diagnostic (IVD) or Medical Device sector

·         Experience working with ISO 13485, FDA regulations for medical devices and directive 98/79/EC and other international standards for IVD and medical devices

·         Experience with US 510(k) submissions

·         Excellent communication, writing and editing capabilities

·         Educated to a minimum of BSc in a Life Science (or related) discipline or with equivalent industry experience. 



The Package:


Our client offers an opportunity to work for a leading medical device company on a permanent basis with a competitive annual salary and benefits package.

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