Job description
Job Title Regulatory Affairs Specialist Job Description The Regulatory Affairs Specialist provides regulatory guidance for CT/AMI product lines and works directly with cross-functional teams to support global market clearances. You will be responsible for regulatory planning, documentation development, and coordination of submissions throughout the product lifecycle. Your role : Serve as the Regulatory Affairs representative for CT/AMI programs, supporting regulatory aspects including labeling, marketing materials, technical documentation, and regulatory assessments related to design changes. Provide regulatory guidance throughout all design control phases for new products and for major/minor design changes. Coordinate, prepare, and review documentation packages to support global submissions and regulatory activities, including US (510(k), EU (Technical Files, DoC), and international registrations. Support global compliance activities including CE marking, clinical evaluations, and compliance with Canada Medical Device Regulations. Support external audits (FDA, Notified Bodies) regarding Regulatory Affairs matters. Act as the local regulatory interface between the markets and the BIU site, and between the site and the global RA organization. Maintain Product Shipment Authorization based on localization and licensing activities. You're the right fit if you have : Relevant academic degree (B.Sc. in engineering and/or life sciences preferred). M.Sc. degree – an advantage 2+ years of experience in a regulated and technical environment Experience working on regulations related to preparation and submission of 510(k), PMA, Technical Files, and international registrations. Strong communication skills and ability to collaborate effectively with cross-functional teams. Excellent English (written and oral). How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. About Philips We 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 culture of impact with care here. Compensation & benefits Doing meaningful work should come with fair, transparent rewards. The base monthly salary range for this grade roles is[15,876]– [ 26,460] ILS . We determine pay within the range using objective factors, like the skills the role requires, your relevant experience and the responsibility you'll have in this role, alongside internal equity and local market considerations. This role is eligible for a bonus, with your rewards linked to KPIs & company results. We'll share the full approach and additional benefits with you during the interview process, so you can make a clear, informed decision. #LI-EU #LI-OFFICE
