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Regulatory Affairs Manager at Philips - ApplyBlast

Regulatory Affairs Manager

Philips

13 days ago

3.8 on Glassdoor

Shenzhen, Guangdong, China

Onsite

Full Time

Manager

0 applicants

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About this role

The Regulatory Affairs Manager supports Personal Health innovation teams in bringing medical and consumer products to market while ensuring compliance with global regulations and company policies. This role involves end-to-end responsibility for Class I and II medical devices, managing regulatory submissions, and collaborating with R&D teams to achieve successful market access. The position requires expertise in EU MDR, U.S. 510(k) clearance, and international medical device submissions.

Responsibilities

Lead regulatory submissions and strategy for medical and consumer products
Manage end-to-end 510(k) clearance and European Technical File preparation
Collaborate with R&D teams to ensure product safety and compliance

Skills

About Philips

philips.com

Headquarters

Amsterdam, North Holland, Netherlands

Company Size

10001+ employees

Founded

1891

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Learn more about Philips and how we help improve people’s lives through meaningful innovation in the areas of Healthcare, Consumer Lifestyle and Lighting.