Safety & Regulatory Engineer
On-site · Suzhou, Jiangsu, China or Shenyang, Liaoning, China
Job Summary
Safety & Regulatory Engineer with a Master’s in Electronics/Electrical/Physics or Biomedical Engineering and 5+ years of engineering experience. Lead and support safety and regulatory tasks including type testing (EMC, safety, performance), prepare submission documents for NMPA, CE and FDA, and manage product registrations/certifications with agencies (NMPA, FDA, EU, NB, etc.). Decompose system-level safety/regulatory requirements to element level, design for compliance, conduct product reviews/inspections, prepare formal testing reports for third-party submissions (NMPA, CB, NRTL), support audits by regulatory bodies, and contribute to safety/regulatory roadmap. Experience with multiple standards (FDA, IEC, ISO, RoHS, WEEE) and knowledge of medical device directives. Office-based with in-person presence at least 3 days per week; onsite roles require full-time presence; field roles may be external to facilities. Proficiency in cross-disciplinary engineering, requirements management, hardware/software testing, and product testing/validation; knowledge of medical diagnostic industry standards and regulatory processes. Philips is an equal opportunity employer.
Required Qualifications
- Master’s degree in Electronics, Electrical, Physics or Biomedical Engineering
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