Regulatory Affairs Manager
Core
Ensures Philips' medical device products comply with global regulatory standards to enable safe and effective healthcare solutions.
Role type
Senior Regulatory Affairs Manager
Builds
Regulatory submissions and compliance documentation for medical devices
Domain
Medical device industry / Global regulatory compliance
Deliverable
client delivery
Required skills
USFDA 510k submission, CE certification, EU MDR, ISO 13485, ISO 14971, 21 CFR 820, Health Canada & CDSCO submission, CAPA management
Preferred skills
Master's degree in scientific field or Engineering, Regulatory Affairs Certification (RAC)
Technologies
FDA, EU MDR, ISO standards
Responsibilities
Collaborate cross-functionally with Quality Assurance, R&D, Engineering, Clinical Affairs, Marketing, and Product Management to ensure compliance throughout the product lifecycle; manage multiple high-stakes regulatory projects simultaneously under strict deadlines.
Seniority
Senior, hands-on IC