Regulatory Affairs Manager

Philips
Pune
Workplace: OnsiteFull timeFunction: Quality & Regulatory (Non-Software)Education: bachelorsSkills: []

You will ensure Philips medical devices comply with global regulatory standards, accelerating approvals while enabling safe, effective healthcare solutions. Collaborating with Regulatory Affairs, QA, R&D/Engineering, Clinical Affairs, Marketing and Product Management, you will navigate multiple regulatory frameworks (FDA, EU MDR, ISO standards) to support lifecycle compliance and drive international collaboration.

Loading

Loading job details...

Preparing the role view and application actions.

FursaFursa
Philips
Philips
5 months ago

Regulatory Affairs Manager

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI
Last checked: 16 hours agoStatus: Live

Job Summary

You will ensure Philips medical devices comply with global regulatory standards, accelerating approvals while enabling safe, effective healthcare solutions. Collaborating with Regulatory Affairs, QA, R&D/Engineering, Clinical Affairs, Marketing and Product Management, you will navigate multiple regulatory frameworks (FDA, EU MDR, ISO standards) to support lifecycle compliance and drive international collaboration.
Location: Pune
Workplace: Onsite
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Manager level

Key Responsibilities

  • •Ensure Philips products comply with global regulatory standards and enable safe and effective healthcare solutions.
  • •Collaborate cross-functionally with Regulatory Affairs Specialists, Quality Assurance, R&D and Engineering, Clinical Affairs, Marketing and Product Management to ensure lifecycle compliance.
  • •Assist with submissions and approvals for multiple markets (FDA, EU MDR, ISO standards, Health Canada, CDSCO) and maintain CAPA processes.
  • •Manage multiple high-stakes regulatory projects simultaneously under tight deadlines.
  • •Stay updated on regulatory frameworks (FDA, EU MDR, ISO 13485, ISO 14971) and advise on product development and lifecycle decisions.

Key Requirements

  • •Typically requires 10-15 years of experience in the medical device industry, with a proven track record of successful submissions.
  • •US FDA 510(k) submission, CE certification, EU MDR, ISO 13485, ISO 14971, 21 CFR 820, Health Canada & CDSCO submission, medical device rules 2017, CAPA.
  • •Bachelor’s degree in a scientific field (Pharmacy, Biology, or Chemistry) or Engineering; a master’s degree or Regulatory Affairs Certification (RAC) is highly preferred.
  • •Ability to manage multiple high-stakes projects simultaneously under strict deadlines.
  • •Capacity to work across global regulatory frameworks and coordinate cross-functional teams.
Experience:Medical devices
Education:Bachelor's in Biology/Chemistry/Pharmacy or Engineering
Certifications:Regulatory Affairs Certification (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
Glassdoor: 3.8
WebsiteLinkedIn