Regulatory Affairs Manager

Job Title Regulatory Affairs Manager Job Description Job title: Regulatory Affairs Manager Your role: • The greater impact of this role.  This role ensures that Philips’ products comply with global regulatory standards, enabling safe and effective healthcare solutions. This directly impacts patient safety, accelerates product approvals, and supports innovation in medical technology. • Detail elements of the team and stakeholders for this role.   You’ll collaborate cross-functionally with Regulatory Affairs Specialists, Quality Assurance, R&D and Engineering, Clinical Affairs, Marketing and Product Management, to ensure compliance throughout the product lifecycle. • What are the professional and personal opportunities for development within this role?    Exposure to global regulatory frameworks (FDA, EU MDR, ISO standards), Opportunities for international collaboration and cultural exposure • From Health and wellness programs to Work-life balance initiatives , a career at Philips comes with all sorts of wonderful benefits. Be sure to speak to your recruiter about benefits in your region.  You're the right fit if:   1. Experience: Typically requires 10-15 years of experience in the medical device industry, with a proven track record of successful submissions. 2. Skills: USFDA 510k submission, CE certification, EU MDR, ISO 13485, ISO 14971, 21 CFR 820, Health Canada & CDSCO submission, medical device rules 2017, CAPA 3. Education: Bachelor’s degree in a scientific field (Pharmacy, Biology, or Chemistry) or Engineering; a master’s degree or Regulatory Affairs Certification (RAC) is highly preferred. 4. Anything else: Capacity to manage multiple high-stakes projects simultaneously under strict deadlines. 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. Indicate if this role is an office/field/onsite role. 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 .