Regulatory Affairs Program Manager
4 days ago
Regulatory Affairs Program Manager
Job SummaryPhilips is seeking a highly skilled Regulatory Affairs Program Manager to join our team. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring our medical devices comply with regulatory requirements.
Key Responsibilities- Regulatory Strategy and Planning
- Develop and implement comprehensive global regulatory strategies for new devices and significant post-market changes.
- Provide accurate and consistent regulatory recommendations, decisions, and feedback to product development and manufacturing teams.
- Regulatory Submissions and Compliance
- Prepare and submit regulatory documents, including 510Ks, PMAs, and EU MDR/MDD submissions.
- Ensure compliance with regulatory requirements, including US CFR, ISO 13485, MDD/MDR, CMDR, MDSAP, and other applicable regulations.
- Regulatory Affairs Support
- Provide regulatory support to product development and manufacturing teams, including design controls and risk management.
- Collaborate with worldwide colleagues to ensure global regulatory compliance.
- Communication and Collaboration
- Communicate effectively with internal stakeholders, including product development and manufacturing teams.
- Collaborate with regulatory agencies and industry partners to stay up-to-date on regulatory requirements and best practices.
- Education and Experience
- Minimum of 7 years of experience in FDA-regulated medical device/healthtech environments.
- Bachelor's degree in Regulatory Affairs and/or a science or engineering-related field. Master's/PhD desired.
- Skills and Knowledge
- Strong background in design controls and risk management.
- Detailed knowledge of medical device regulations, including 21CFR, MDD/MDR, and other global laws and standards.
- Experience with international registrations and/or clinical investigations.
- Proven understanding of LEAN concepts, methodologies, and deployment.
- Physical, Cognitive, and Environmental Job Requirements
- Ability to perform the minimum physical, cognitive, and environmental job requirements with or without accommodation.
Philips is a health technology company dedicated to improving the lives of patients and healthcare professionals around the world. We are committed to innovation, quality, and customer satisfaction.
What We OfferPhilips offers a comprehensive benefits package, including a competitive salary, comprehensive health insurance, retirement savings plan, and opportunities for professional growth and development.
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