Role: Regulatory Affairs Project Manager 12 Month FTC
Location: North Yorkshire
Salary: £50,000 + Bonus + Excellent Benefits
Russell Taylor Group has a fantastic opportunity for someone with a Medical Device background that specialises in Regulatory Affairs to join a Global Medical Device company and assist them with tasks relating to EU MDR.
Travel to other UK sites will be required.
- Manage, guide and support Regulatory Affairs Associates involved in the preparation, submission and/or maintenance of market registration documentation (EU Technical Files, Design Dossiers, US 510(K), PMA, etc.) and related activities.
- Establish and maintain market registration documentation necessary to achieve international market registration objectives.
- Establish and maintain a regulatory intelligence reference source for international markets, providing training to regulatory staff, and keeping the company in compliance and up to date with regulatory developments.
- Provide regulatory direction and support to New Product Developments, Line Extensions, and Base Business products, including regulatory strategy for key customers to assist in building relevant stock builds during site transfers.
- Provide support to deliver EUMDR requirements for all key customers.
- Develop and maintain up to date department standard operating procedures and work instructions.
- Maintain appropriate records/archives on behalf of the department and according to company records retention policy.
- Comply with site Health and Safety procedures.
- Experience within a highly regulated medical devices industry sector.
- Good analytical and research skills.
- Project Management experience
- Degree in relevant technical/scientific field and/or 4-5 years previous Regulatory experience within the same industry and with similar wound management products.
- Full UK Driving licence and required to travel to other UK sites.
Keywords; Regulatory Affairs, RA, Medical Devices, ISO 13485,