Philips

4 days ago

Safety & Regulatory Engineer

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 14 hours agoStatus: Live

Job Summary

Plan, schedule, and execute medical device safety and regulatory work, including EMC, safety, and performance type testing, and preparing submission documents for NMPA, CE, and FDA. Translate system-level requirements into element-level requirements, design for safety and compliance, and conduct product reviews and inspections. Own product type testing reports, manage product certifications with agencies, lead marketing clearance and registrations in R&D, and support audits and a safety & regulatory roadmap.

Location: Suzhou

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Mid level

Key Responsibilities

•Plan, schedule, manage, conduct, and support safety and regulatory tasks including type testing (EMC, safety, performance) and submission documentation for NMPA, CE, and FDA.
•Decompose system-level safety and regulatory requirements into element-level requirements and design for safety and compliance to applicable standards.
•Conduct product reviews and inspections according to standards requirements and prepare formal product type testing reports for third-party submissions (e.g., NMPA, CB, NRTL).
•Work with agencies (e.g., NMPA, NB, FDA) to obtain product certifications and lead marketing clearance and product registrations activities within R&D (NMPA, FDA, EU).
•Support and prepare for audits with agencies including NMPA, CE, MADSAP, and others (e.g., Russia, Korea, Brazil) while maintaining the product safety & regulatory roadmap.

Key Requirements

•Master’s degree in Electronics, Electrical, Physics, or Biomedical Engineering (Computer science & technology) plus 5+ years engineering experience.
•Proficiency in medical device safety and compliance, including design for safety and test methods.
•Proven experience with medical device marketing clearance and product registrations (NMPA, FDA, EU).
•Deep knowledge of Design for EMC and practical experience with medical device standards and regulations (e.g., FDA, IEC, ISO, NMPA) and directives such as RoHS and WEEE.
•Experience with project and process management for safety and regulatory activities.

Experience:5+ yearsMedical devicesMedical diagnosticRegulatory compliance

Education:Master's in Electronics, Electrical, Physics, Biomedical Engineering, or Computer science & technology

Skills:Requirements ManagementSystems EngineeringRequirements AnalysisProduct Testing & ValidationProject/process management

Tech Stack:EMCNMPACEFDAIECISORoHSWEEEFDA 21CFR820.30IEC 60601-1IEC 60601-1-2IEC 60601-1-3IEC 60601-2-44IEC 62304IEC 62366-1ISO 14971

Company Brief

Philips

Global health technology company focusing on diagnostic imaging, patient monitoring, and consumer health products. Philips develops medical devices, healthcare informatics, and solutions to improve patient care and personal well-being.

Industry: HealthTech

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Amsterdam, Netherlands

Founded: 1891

Glassdoor: 3.8

Website LinkedIn

Loading job details...

Preparing the role view and application actions.

Philips

4 days ago

Safety & Regulatory Engineer

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 14 hours agoStatus: Live

Job Summary

Location: Suzhou

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Mid level

Key Responsibilities

•Plan, schedule, manage, conduct, and support safety and regulatory tasks including type testing (EMC, safety, performance) and submission documentation for NMPA, CE, and FDA.
•Decompose system-level safety and regulatory requirements into element-level requirements and design for safety and compliance to applicable standards.
•Conduct product reviews and inspections according to standards requirements and prepare formal product type testing reports for third-party submissions (e.g., NMPA, CB, NRTL).
•Work with agencies (e.g., NMPA, NB, FDA) to obtain product certifications and lead marketing clearance and product registrations activities within R&D (NMPA, FDA, EU).
•Support and prepare for audits with agencies including NMPA, CE, MADSAP, and others (e.g., Russia, Korea, Brazil) while maintaining the product safety & regulatory roadmap.

Key Requirements

•Master’s degree in Electronics, Electrical, Physics, or Biomedical Engineering (Computer science & technology) plus 5+ years engineering experience.
•Proficiency in medical device safety and compliance, including design for safety and test methods.
•Proven experience with medical device marketing clearance and product registrations (NMPA, FDA, EU).
•Deep knowledge of Design for EMC and practical experience with medical device standards and regulations (e.g., FDA, IEC, ISO, NMPA) and directives such as RoHS and WEEE.
•Experience with project and process management for safety and regulatory activities.

Experience:5+ yearsMedical devicesMedical diagnosticRegulatory compliance

Education:Master's in Electronics, Electrical, Physics, Biomedical Engineering, or Computer science & technology

Skills:Requirements ManagementSystems EngineeringRequirements AnalysisProduct Testing & ValidationProject/process management

Tech Stack:EMCNMPACEFDAIECISORoHSWEEEFDA 21CFR820.30IEC 60601-1IEC 60601-1-2IEC 60601-1-3IEC 60601-2-44IEC 62304IEC 62366-1ISO 14971

Company Brief

Philips

Industry: HealthTech

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Amsterdam, Netherlands

Founded: 1891

Glassdoor: 3.8

Website LinkedIn