Regulatory Affairs Manager

Philips
Suzhou
Workplace: OnsiteFull timeFunction: Quality & Regulatory (Non-Software)Experience: 5+ yearsEducation: bachelorsSkills: ["Attention to detail","Written communication","Oral communication","Interpersonal communication","Stakeholder management"]

Own regulatory strategy and submissions for medical devices in the People’s Republic of China. Coordinate device registrations, approvals, amendments, and maintain regulatory files and tracking databases. Advise internal stakeholders on guidance and agency initiatives, create written regulatory plans aligned to shipment targets, and oversee China CFDA submissions. Communicate with regulatory agencies and support global registrations with the Greater China RA team.

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Philips
Philips
1 month ago

Regulatory Affairs Manager

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Source: Company careers pageValidated by: Fursa AI
Last checked: 27 days agoStatus: Live

Job Summary

Own regulatory strategy and submissions for medical devices in the People’s Republic of China. Coordinate device registrations, approvals, amendments, and maintain regulatory files and tracking databases. Advise internal stakeholders on guidance and agency initiatives, create written regulatory plans aligned to shipment targets, and oversee China CFDA submissions. Communicate with regulatory agencies and support global registrations with the Greater China RA team.
Location: Suzhou
Workplace: Onsite
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Manager level

Key Responsibilities

  • •Coordinate, review, and file new device registrations/approvals and amendments for market access in China.
  • •Advise internal stakeholders and align market access strategy with local and international marketing/sales requirements.
  • •Create detailed written regulatory plans to target domestic and international shipment dates.
  • •Develop and take ownership of China CFDA submissions, including maintaining files and tracking databases.
  • •Establish communications with regulatory agencies in China and review/approve advertising, promotional items, and labeling for regulatory compliance.

Key Requirements

  • •BS in an engineering discipline (or equivalent education/experience/training).
  • •At least 5 years of regulatory experience in the medical device industry.
  • •Strong understanding of China FDA and other major international regulations.
  • •Experience with China locally manufactured or locally developed products (plus).
  • •Ability to manage multiple tasks with high accuracy and attention to detail, and compose agency submissions with strong written, oral, and interpersonal skills.
Experience:5+ yearsMedical device industry
Education:Bachelor's
Skills:Attention to detailWritten communicationOral communicationInterpersonal communicationStakeholder management

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
Glassdoor: 3.8
WebsiteLinkedIn