|Job Ref:||204768987||Employer:||cv-library.co.uk||Industry:||Civil and Structural||Job Type:||Permanent||Country:||United Kingdom||City:||South East London||Address:||Salary:||£40000 - £50000/annum Benefits||Post Date:||11/10/2016 04:08|
Austin Fraser are again pleased to be representing the world leader in their field of Medical Device manufacturing. Our client have revenues of over £10 billion and are based in over 35 countries worldwide with some of the best career progression opportunities available.|
The position on offer is a Senior Regulatory Specialist position reporting into the Head of European Regulatory Affairs. The position itself has exceptional scope for progression for those individuals looking to further their career.
* Be the primary RA representative for the products as well as RA representative for site based activities
* Develop and deploy global regulatory strategies and manage the pre-market submission of the products as well as assist with the registration of distributed products as necessary
* Act as the lead RA within a cross-functional project team, providing inputs into New Product Development, changes to existing products and other activities involving the complete life-cycle management of products
* Be responsible for the planning and implementation of new and updated regulations as applicable while working in coordination with global regulatory affairs
* Assist Line Manager in gathering relevant KPI and metrics
* Lead change projects and site quality review meetings
You should have at least 2 years experience in a pre market Regulatory Affairs position along with excellent experience of CE marking Medical Device or IVD's. Any 510k experience would be advantageous.
Due to the company stature and renowned opportunity for progression within the business, this opportunity is likely to be very popular for those interested in a new challenge. If you would like to find out more please contact Ash Blanchard on NA or