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Thermo Fisher Scientific
,
Paisley, Renfrewshire
Sr Regulatory Affairs Specialist
Overview
Job Description
The job: Senior Regulatory Affairs Specialist (Band 7) The Senior Regulatory Specialist is a role in our Life Science Solutions Group. The purpose of this role will to be responsible for managing In-Vitro Diagnostic (IVD) Medical Device regulatory submissions and regulatory compliance activities in line with corporate and divisional objectives. In addition, the position will provide regulatory support to customers with respect to legislative requirements for the market place, mainly EMEA. Where will you work? This role can be home based anywhere in the UK. What will you do? * Compile, review and maintain regulatory submissions, Technical Files, and labelling for completeness and quality. * Maintain and update dossiers for existing Marketing Authorizations. * Identify regulatory requirements for new product and changes to existing products. * Determine the scope of information/documentation necessary to file new registration applications and post-approval changes to regulatory agencies. * Contribute within new product development projects to ensure compliance with internal product commercialization process (PCP) and global regulations. * Review and approve product labelling/marketing materials for compliance with applicable regulations and standards. * Review new and existing EMEA regulations, guidance documents and standards, and prepare comments based on impact to product and business. * Support post-market surveillance and vigilance activities, including submitting reports to authorities. * Participate in internal and external company regulatory/quality audits, and assist corporate in carrying out GMP cross-site audits. * Participate in customer audits/technical meetings when applicable. * Develop regulatory affairs internal policies and procedures, and provide internal trainings as and when required. * May be required to perform other related duties as required and/or assigned. * Has contact with all levels of company employees as well as frequent interactions with varies external regulatory agencies, authorities, distributors and customers. How will you get here? * Bachelor's degree in Biology or similar field, from an accredited college or university or equivalent experience. * A strong working knowledge of In-Vitro Diagnostic/Medical Device regulatory affairs environment including but not exclusive to: Regulations, Submissions and Technical Files. * Experience of communicating with Regulatory Authorities and Distributors * Experience in clinical trials, specifically regulatory activities and submissions for the trials * Experience in regulatory audits, ISO certification, GMP requirements and document control. * Warrington office or UK Remote. Some travel required: 20%. At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer. Employment Type: Full time