Safety & Regulatory Engineer

Philips

Safety & Regulatory Engineer responsible for safety and compliance in medical devices at Philips. Handling regulatory tasks, product certifications, and leading marketing clearance activities.

Posted 6/16/2026full-timeSuzhou • 🇨🇳 ChinaMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

Plan, schedule, manage, conduct and support safety and regulatory tasks (e.g., type testing including EMC, Safety, performance..., submission documents for NMPA, CE and FDA) with projects assigned
Decompose system level safety and regulatory requirements to element level.
Design for safety and compliance to meet the standards and regulation
Conduct product reviews and inspections according to standards requirements
Prepare formal product type testing reports for submission with Third-party agencies including NMPA, CB and NRTL
Work with different agencies including NMPA, NB and FDA to obtain product certifications
Lead marketing clearance and product registrations activities internally in R&D (NMPA, FDA, EU)
Support audits conducted by NMPA, CE, MADSAP, Russia, Korean and Brazil etc
Product Safety & Regulatory roadmap

Requirements

What you’ll need

Master’s degree in Electronics, Electrical, Physics or Biomedical Engineering
5+ years engineering experience
Proficiency with medical device safety and compliance, e.g., design for safety, test methods
Proven excellence in the process of medical device marketing clearance and product registrations (NMPA, FDA, EU)
Deep insight in 'Design for EMC' for complicated medical devices
Knowledge and experience spanning multiple engineering disciplines (e.g. electrical, electronics, physics and systems engineering) is advantageous.
Medical diagnostic industry awareness
Evidence of practical knowledge of standards and regulations pertaining to medical device industry, both domestic and international.
Knowledge and experience spanning multiple engineering disciplines (e.g. electrical, electronics, physics and system engineering) is advantageous.
Experience in Project and process management.

Benefits

Comp & perks

We believe that we are better together than apart.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

medical device safetydesign for safetytest methodsmarketing clearanceproduct registrationsDesign for EMCproject managementprocess managementsystem level safety requirementselement level safety requirements

Certifications

Master’s degree in ElectronicsMaster’s degree in Electrical EngineeringMaster’s degree in PhysicsMaster’s degree in Biomedical Engineering