Regulatory Affairs Manager

Philips

. Support Personal Health innovation teams in bringing products to market while complying with external regulations, standards, and company product safety and compliance policies .

Posted 10/15/2026full-timeShenzhen • ChinaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory submissions and compliance for medical devices, including 510(k) clearance and CE marking. Possesses strong analytical and project management skills, with proficiency in risk management and technical writing.

Highest-signal resume keywords

Regulatory Submissions510(k) ClearanceRisk Management (IEC 14971)EUDAMED and UDI RequirementsTechnical Writing

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentProduct DevelopmentAnalytic CapabilitiesProject ManagementTechnical File Preparation

Soft Skills

Good CommunicatorNetwork-Oriented Mind-SetTeam PlayerSolution Seeking Mind-SetInterpersonal Skills

Industry Keywords

Medical DevicesConsumer ProductsEU MDRMDDCE Marking

About the role

Key responsibilities & impact

Support Personal Health innovation teams in bringing products to market while complying with external regulations, standards, and company product safety and compliance policies
Guide the business through the regulatory landscape
Own regulatory submissions, including initial registrations, changes/variations, and international renewals
Develop approval plans and regulatory strategy plans
Work with applicable test houses, notified bodies, and other regulatory authorities
Prepare and maintain the European Technical File for CE marking
Manage end-to-end 510(k) clearance in the U.S.
Support EU MDR and international medical device submissions
Participate in medical device and consumer product development teams
Drive early collaboration with R&D to ensure products meet safety, compliance, and regulatory requirements and achieve successful market access
Report to the Team Lead of RA, MCC Business in the Netherlands

Requirements

What you’ll need

University Degree
5 years of experience in product development projects of electronics in medical devices (consumer products a plus)
Experienced in Risk Management (IEC 14971)
(Previous) experience with successful 510k clearance
(Previous) experience with MDD and MDR Technical file for Class I and Class IIa products
Experience with EUDAMED, UDI requirements
Proven analytic capabilities and product knowledge – system thinking
A network-oriented mind-set and ability to interact with different business functions at all levels
Technical writing and project management skills
Very good English and Chinese skills required
Conceptual, analytical, data driven, and hands-on, getting things done mentality
Subject leader and team player
Good communicator skilled in managing interpersonal processes
Quality oriented and solution seeking mind-set