Senior Regulatory Affairs Specialist

Philips
Washington
Workplace: OnsiteFull timeFunction: Quality & Regulatory (Non-Software)Education: bachelorsSkills: ["Communication","Problem-solving","Attention to detail"]

Senior Regulatory Affairs Specialist to support regulatory strategy, submissions, and compliance for Philips products. The role collaborates with cross-functional teams, interprets regulatory requirements, and maintains regulatory intelligence to ensure lifecycle compliance across markets. This position involves preparing documentation, interfacing with regulatory authorities, and guiding product development from a regulatory perspective.

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Philips
Philips
4 months ago

Senior Regulatory Affairs Specialist

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Last checked: 22 hours agoStatus: Live

Job Summary

Senior Regulatory Affairs Specialist to support regulatory strategy, submissions, and compliance for Philips products. The role collaborates with cross-functional teams, interprets regulatory requirements, and maintains regulatory intelligence to ensure lifecycle compliance across markets. This position involves preparing documentation, interfacing with regulatory authorities, and guiding product development from a regulatory perspective.
Location: Washington
Workplace: Onsite
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Sr. Manager level

Key Responsibilities

  • •Lead the regulatory strategy, planning, and submissions for products to ensure compliance with applicable laws and guidelines
  • •Prepare, compile, and submit regulatory documentation and maintain regulatory files throughout product lifecycle
  • •Liaise with regulatory authorities and external partners to resolve submission questions and approvals
  • •Monitor and interpret regulatory developments and maintain regulatory intelligence for impacted products
  • •Collaborate with cross-functional teams (R&D, quality, clinical, manufacturing) to ensure timely and compliant product development

Key Requirements

  • •Bachelor's degree in a life sciences field or related discipline
  • •Relevant experience in regulatory affairs within the healthcare/medical devices/pharmaceutical sector
  • •Ability to prepare and submit regulatory documentation and manage submissions
  • •Strong understanding of regulatory requirements and guidance across key markets
  • •Excellent communication and analytical skills with attention to detail
Experience:HealthcareMedical DevicesPharmaceuticals
Education:Bachelor's
Skills:CommunicationProblem-solvingAttention to detail

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