Regulatory Affairs Manager

Your role:
The greater impact of this role.

This role ensures that Philips products comply with global regulatory standards, enabling safe and effective healthcare solutions. This directly impacts patient safety, accelerates product approvals, and supports innovation in medical technology.

Detail elements of the team and stakeholders for this role.

You ll collaborate cross-functionally with Regulatory Affairs Specialists, Quality Assurance, R&D and Engineering, Clinical Affairs, Marketing and Product Management, to ensure compliance throughout the product lifecycle.

What are the professional and personal opportunities for development within this role

Exposure to global regulatory frameworks (FDA, EU MDR, ISO standards), Opportunities for international collaboration and cultural exposure

From Health and wellness programs to Work-life balance initiatives , a career at Philips comes with all sorts of wonderful benefits. Be sure to speak to your recruiter about benefits in your region.

Youre the right fit if:
1. Experience: Typically requires 10-15 years of experience in the medical device industry, with a proven track record of successful submissions.
2. Skills: USFDA 510k submission, CE certification, EU MDR, ISO 13485, ISO 14971, 21 CFR 820, Health Canada & CDSCO submission, medical device rules 2017, CAPA
3. Education: Bachelor s degree in a scientific field (Pharmacy, Biology, or Chemistry) or Engineering; a master s degree or Regulatory Affairs Certification (RAC) is highly preferred.
4. Anything else: Capacity to manage multiple high-stakes projects simultaneously under strict deadlines.