This role ensures that Philips' products comply with global regulatory standards, enabling safe and effective healthcare solutions
Job Summary
This role ensures that Philips' products comply with global regulatory standards, enabling safe and effective healthcare solutions.
You will collaborate cross-functionally with Regulatory Affairs Specialists, Quality Assurance, R&D, and Engineering to ensure compliance throughout the product lifecycle.
The position offers exposure to global regulatory frameworks including FDA, EU MDR, and ISO standards alongside opportunities for international collaboration.
Matching Summary
Match Score: 85
This role ensures that Philips' products comply with global regulatory standards, enabling safe and effective healthcare solutions.
Skills & Requirements
Must-have
10-15 years medical device experience
USFDA 510k submission expertise
EU MDR and CE certification knowledge
ISO 13485 and ISO 14971 standards
21 CFR 820 and CAPA management
Nice-to-have
Cross-functional collaboration skills
International cultural exposure
Ability to manage multiple high-stakes projects
Strong work-life balance initiatives
Key Requirements
Bachelor's degree in scientific field or Engineering
Master's degree or Regulatory Affairs Certification (RAC) preferred