Regulatory Affairs Program Manager

4 days ago


Des Plaines, Illinois, United States Philips Full time
Job Title

Regulatory Affairs Program Manager

Job Summary

Philips 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.
Requirements
  • 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.
About Philips

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 Offer

Philips 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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