Philips

2 days ago

Regulatory Affairs Manager

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 18 hours 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: 3.8

Website LinkedIn

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Philips

2 days ago

Regulatory Affairs Manager

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 18 hours agoStatus: Live

Job Summary

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

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