Job Description
Job TitleSr. Regulatory Affairs SpecialistJob DescriptionJob title: Sr. Regulatory Affairs SpecialistYou will be part of the Regulatory Affairs team for our Diagnostic X-Ray unit within Precision Diagnosis business segment and therefore, influence and shape the regulatory capabilities for future success of Philips.Your role:Responsible for implementing global regulatory and roadmaps through understanding the competitive market landscape and product marketing strategy.Advises product design teams on regulatory strategy and requirements for specific new products/solutions.Responsible for regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.Supports development of the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, and Product registrations such as CE Marking and clinical evaluations.Develops and facilitates regulatory submissions for new products/solutions, existing products/solutions.Creates, reviews and validates marketing and labeling materials while supporting projects and other key regulatory initiatives.You're the right fit if:You have Bachelor's or Master’s degree or equivalent, preferably in Engineering, Life Scientific field and/or Informatics.Minimum of 10 years of experience working in Regulatory Affairs within a medical device industry.Extensive knowledge and authoring of FDA and other regulatory submissions (Pre-submissions, IDE, 510(k), PMA, Technical Files/Design Dossier).Extensive knowledge of MDD, MDR, MedDev’s, QMS standards, safety risk management, software development, cybersecurity and labeling standards, other applicable regulations, standards and applications.Experienced in strategic relationships with external stakeholders (e.g., Notified Bodies, FDA, Competent Authorities).Experienced in formulating and implementing global regulatory strategies to ensure compliance with worldwide regulations to improve product market access.An excellent communicator and collaborator who can build and maintain cross-functional partnerships in support of business successes.Self-directed with a strong work ethic and with an ability to work in a goal-oriented environment.An ability to work on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. Follows processes and operational policies in selecting methods and techniques for solutions.Demonstrated experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL.About 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-PHILIN#DIW
