Regulatory Affairs Specialist (IVDR)

Brief role summary: Thermo Fisher Scientific is seeking a Regulatory Affairs professionals to assist with accelerating the Business's preparations to meet the requirements of the forthcoming IVD Regulation. The roles will encompass assessing existing technical documentation, assisting with defining a strategy to implement timely actions and compilation and inspection of technical information designed to keep our products in compliance with European Regulation. The Regulatory Affairs Specialist will report to the Regulatory Affairs Manager (ID, AST & Instrumentation). Responsibilities: * Implement regulatory strategy across a wide portfolio of devices to ensure that company products are safe, legal and meet expectations for compliance with European regulations * Assess, report on and action any gaps in current technical information * Work closely with the Technical teams and Project Management to ensure timely delivery of goals * Generate records and documentation for inclusion into device-supporting Technical information * Collaborate and assist with the digitization project to enable faster access to technical information Minimum Qualifications/Experience: * Degree or HND in Science, Life Sciences or Engineering * Experience within the IVD or medical device industry * Excellent IT skills Preferred Skills/Experience: * Knowledge of IVD Directive * Excellent attention to detail * Ability to plan multiple tasks and effectively prioritize activities * Capability to drive assignments to completion * Effective communicator with management, peers and internal customers * Experience of working with active devices (IEC 60601, IEC 61010, IEC 62304) would be an advantage * Pro-active with proven ability to work under own initiative, and strong team player * Current full Driving License. At Thermo Fisher Scientific, each one of our 70,000 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. Apply today! Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. Employment Type: Full time