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Fortem People
,
Skipton, North Yorkshire
Regulatory Affairs Manager
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Salary: £50,000 per annum |
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Overview
Our client is a leading global organisation who manufactures products for healthcare and industrial markets. They have a new role to oversee a project manager wihtin regulatory affairs for 12 months - this may well be extended further. Successful candidates must come from a highly regulated, medical devices/pharma background and have the below skills: Project Management experience Good analytical and research skills Medical devices industry sector experience Experience of working within a highly regulated environment A degree in technical/scientific field and/or previous regulatory experience within the same industry or related industry Role duties and responsibilities: 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.