Senior Regulatory Affairs Specialist

TXM Recruit
Bexley, Greater London
£50000 - £60000/annum bonus and benefits package
14 Jul 2017
13 Aug 2017
Contract Type
Full Time
Senior Regulatory Affairs Specialist

£50,000-£60,000 plus bonus and range of benefits


IVD / Medical Devices

Job description

We are working with a true global market leader in the IVD and Scientific Research markets who have an exciting 3-year growth plan to further strengthen their market share and revenue through their continued investment in research and innovation with a big focus on new product introduction.

As part of their strategies they are looking to strengthen their regulatory affairs expertise and appoint a new Senior Regulatory Specialist for premarket activities; playing a lead role in key projects around new product development and international registrations.

You will be working closely with the Regulatory Affairs Manager for Europe and joining a close knit and experienced team of 5.

Role Responsibilities:
- Be the primary Regulatory Affairs representative for diagnostics products for which the site has responsibility as well as RA responsibility for distribution activities of other company products.
- Develop and deliver global regulatory strategies and manage the pre-market submission of products.
- Provide Regulatory advice and input into New Product Development, changes to existing products.
- This position will cover Regulatory Affairs for the complete life-cycle management of products
- Lead change projects and site quality review meetings

Essential Experience and Qualifications:
- Proven experience in Regulatory Affairs and submissions within the IVD or medical devices industries.
- Experienced in submission or Technical File compilation.
- Experience in navigating complex pre-market submissions for instance 510k submissions for the US Market.
- Strong project management and organisational skills to work across multiple product areas and markets.

If you have the necessary experience in Regulatory Affairs within Medical Devices or IVD and would be motivated to work within a fast-paced market leading company, then please send your CV and contact James Powell of TXM Recruit.

TXM Recruit is an equal opportunities employer. If you have any specific requirements or require assistance or reasonable adjustments to be made for you during the selection process due to disability or long-term health condition, we will do our best to assist you