This role involves leading a team of 8 Safety & Compliance Managers and Regulatory specialists for Mother & Child Care products
Job Summary
This role involves leading a team of 8 Safety & Compliance Managers and Regulatory specialists for Mother & Child Care products.
The successful candidate will ensure all products meet global regulatory standards including EU MDR and FDA requirements while managing submissions and approvals.
Philips is a health technology company committed to ensuring quality healthcare access for everyone, requiring in-person work at least 3 days per week.
Matching Summary
This role involves leading a team of 8 Safety & Compliance Managers and Regulatory specialists for Mother & Child Care products.
Skills & Requirements
Must-have
5 years Regulatory Affairs experience
Medical Device development standards knowledge
Team management of Safety & Compliance staff
EU MDR and FDA 510K regulatory expertise
Global product registration and approbation
Nice-to-have
Strong analytical and structured working style
Proactive approach to transformation
Affinity with Mother & Child Care products
Experience influencing industry standards
Cross-functional collaboration skills
Key Requirements
Bachelor's degree with 5+ years experience OR Master's with 3+ years
Extensive knowledge of ISO13485 and 21CFR820 regulations
Proven track record in global medical device registration
Demonstrated leadership and team management experience