Regulatory Affairs Manager

Job Description

Job title:
Regulatory Affairs Manager

Your role:
u2022 The greater impact of this role.u00A0

This role ensures that Philipsu2019 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.

u2022 Detail elements of the team and stakeholders for this role.u00A0

Youu2019ll 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.

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

u2022 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.u00A0

You're the right fit if: u00A0
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: Bacheloru2019s degree in a scientific field (Pharmacy, Biology, or Chemistry) or Engineering a masteru2019s degree or Regulatory Affairs Certification (RAC) is highly preferred.
4. Anything else: Capacity to manage multiple high-stakes projects simultaneously under strict deadlines.

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the companyu2019s facilities.
Field roles are most effectively done outside of the companyu2019s main facilities, generally at the customersu2019 or suppliersu2019 locations.
Indicate if this role is an office/field/onsite role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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If youu2019re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care .