Description
I am currently urgently seeking a QA/RA Manager for my client in the South East. My client is a Multinational Medical Device Company that now has a need for a highly skilled professional to join their Successful team.This role is to support the Inspection Manager and the Technical Director in maintaining the company's compliance to both EU and US regulations.
General responsibilities include;
- Run QA team and delegate audit and QMS responsibilities.
- Provide strategic leadership, to successfully manage and coming product launch.
- Deal with hands on Regulatory activity in the EU and US territories.
- Compilation of product dossiers for Regulatory Submissions.
- Ensure products are successfully CE marked by relevant authorities.
- Implement a QA system streamlining.
- Management of current QA function.
Essential Requirements;
- Substantial proven Regulatory & Quality Management experience in a Medical Device company.
- Experience of strategic & hands on regulatory affairs.
- Previous experience working with the FDA, 510k's, PMA'a etc.
- Previous interaction with the European and USA regulatory bodies.
- Experience with the regulatory and quality procedures connected with class III &Class II Medical Devices.
- Experience of the management of a Medical Device Quality management system to ISO 13485.
- Willingness to travel internationally.
This client is looking to pay £50,000 - £65,000 + Benefits for the correct candidate for this position so if you feel you have the right experience for the role, please send me your CV and I will be in touch shortly.