Philips

4 days ago

Associated Regulatory Affairs Manager

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 11 hours agoStatus: Live

Job Summary

Support regulatory strategy implementation for smaller, less complex projects by partnering with regulatory and cross-functional SMEs to ensure compliance with applicable requirements. Under general supervision, contribute to Quality System understanding, conformity assessment planning, and regulatory submission coordination for product licensing, device updates, and change control. Collaborate with central/regional teams on registrations, UDI/GTIN activities, and review product labeling and marketing communications to support market access and approval timelines.

Location: Suzhou

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Key Responsibilities

•Assist in implementing regulatory strategies with regulatory and cross-functional SMEs to ensure compliance for limited-scope projects.
•Collaborate with central and regional Regulatory Affairs teams on establishment registration/listing and UDI/GTIN-related activities.
•Support conformity assessment strategy and plans for regulatory submissions aligned to requirements and standards.
•Coordinate and prepare regulatory submissions for product/solution licensing, ensuring accuracy and managing files for device updates and change control.
•Review product/solution labeling and related marketing communications for regulatory compliance; keep abreast of regulatory procedures/changes and support process improvements.

Key Requirements

•Bachelor’s degree or vocational education in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law, or equivalent.
•No prior experience required with a Bachelor’s degree, or minimum 4 years of experience with vocational education in Regulatory Affairs, Quality Compliance, Product Development in the Medical Devices industry, or equivalent.
•Familiarity with regulatory’s role in the Quality System and general knowledge of product lines, disease states, and customers.
•Ability to apply analytical skills to resolve less complex regulatory requests within defined procedures.
•Preferred: RAPS RAC certification.

Experience:4+ yearsMedical devicesRegulatory affairsQuality complianceProduct development

Education:Bachelor's in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law

Skills:Independent judgmentAnalytical skillsStakeholder managementContinuous improvementDocument auditingData managementStrategy implementationAdministrative support

Certifications:RAPS RAC

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

4 days ago

Associated Regulatory Affairs Manager

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 11 hours agoStatus: Live

Job Summary

Location: Suzhou

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Key Responsibilities

•Assist in implementing regulatory strategies with regulatory and cross-functional SMEs to ensure compliance for limited-scope projects.
•Collaborate with central and regional Regulatory Affairs teams on establishment registration/listing and UDI/GTIN-related activities.
•Support conformity assessment strategy and plans for regulatory submissions aligned to requirements and standards.
•Coordinate and prepare regulatory submissions for product/solution licensing, ensuring accuracy and managing files for device updates and change control.
•Review product/solution labeling and related marketing communications for regulatory compliance; keep abreast of regulatory procedures/changes and support process improvements.

Key Requirements

•Bachelor’s degree or vocational education in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law, or equivalent.
•No prior experience required with a Bachelor’s degree, or minimum 4 years of experience with vocational education in Regulatory Affairs, Quality Compliance, Product Development in the Medical Devices industry, or equivalent.
•Familiarity with regulatory’s role in the Quality System and general knowledge of product lines, disease states, and customers.
•Ability to apply analytical skills to resolve less complex regulatory requests within defined procedures.
•Preferred: RAPS RAC certification.

Experience:4+ yearsMedical devicesRegulatory affairsQuality complianceProduct development

Education:Bachelor's in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law

Skills:Independent judgmentAnalytical skillsStakeholder managementContinuous improvementDocument auditingData managementStrategy implementationAdministrative support

Certifications:RAPS RAC

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