Regulatory Affairs Specialist

Job TitleRegulatory Affairs SpecialistJob DescriptionJob title:Regulatory Affairs SpecialistThe Regulatory Affairs Specialist provides regulatory guidance for business unit product lines. The Regulatory Affairs Specialist works directly with cross-functional teams to support global product market clearances.Your role:Regulatory Affairs representative for business unit Programs and assists with regulatory matters such as labeling, marketing, technical documents, and regulatory design change assessment required in the Development Life CycleSupport the cross-functional teams with regulatory guidance during all design control phases of a new product, major and/or minor changesDirectly responsible for the coordination and preparation of document packages to support global submissions and regulatory activities, including US, EU and Canada [510(k) Pre-market Notifications, PMAs, Product Reports/Supplements, GUDID (UDI), Technical Files, Declarations of Conformity, International Medical Device LicensesGuide global compliance, such as CE Marking and product registrations, clinical evaluations, Canada Medical Device Regulations, etcSupport in external audits (e.g., FDA, CFDA, KFDA, PMDA, Notified Bodies) for Regulatory Affairs mattersServes as local regulatory interface between the markets and the BIU siteServes as local regulatory interface for the global business RA teamMaintains Product Shipment Authorization for business unit product lines based on completion of localization and licensing.You're the right fit if you have:Relevant academic degree, B.Sc. in engineering and/or life science is preferableKnowledge of the relevant global regulations for successful preparation and submission of 510(k), PMA, TF and international registrations worldwideAbility to communicate effectively with cross-functional teamsExcellent English skills (written and oral)M.Sc. - an advantageCertified regulatory affairs professional- an advantageAbout PhilipsWe are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.• Learn more about our business.• Discover our rich and exciting history.• Learn more about our purpose.If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.#LI-EU