Head of Regulatory, AM & D

Philips
Cambridge, Chicago
Workplace: HybridFull timeUSD 183,000 - 291,000 annuallyFunction: Quality & Regulatory (Non-Software)Experience: 8+ yearsSkills: ["Communication","Stakeholder management","Risk mitigation","Cross-functional collaboration","Continuous improvement"]

Lead global regulatory strategy for Ambulatory Monitoring & Diagnostics, serving as the primary liaison between regulatory authorities and internal stakeholders. Manage a Regulatory Affairs team, mitigate regulatory risks, and oversee product registrations, approvals, CE Marking, clinical evaluations, submissions, and change management across the product lifecycle. Partner cross-functionally to embed regulatory requirements into product development and business processes while driving continuous improvement and regulatory excellence.

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Philips
Philips
1 week ago

Head of Regulatory, AM & D

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Last checked: 16 hours agoStatus: Live

Job Summary

Lead global regulatory strategy for Ambulatory Monitoring & Diagnostics, serving as the primary liaison between regulatory authorities and internal stakeholders. Manage a Regulatory Affairs team, mitigate regulatory risks, and oversee product registrations, approvals, CE Marking, clinical evaluations, submissions, and change management across the product lifecycle. Partner cross-functionally to embed regulatory requirements into product development and business processes while driving continuous improvement and regulatory excellence.
Location: Cambridge, Chicago
Workplace: Hybrid
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Sr. Director level

Key Responsibilities

  • •Establish and execute global regulatory strategy aligned to business objectives and market access decisions.
  • •Lead and develop a global Regulatory Affairs organization, including direction, talent development, succession planning, and performance management.
  • •Drive regulatory compliance across the product lifecycle, overseeing registrations, approvals, CE Marking, clinical evaluations, submissions, and change management.
  • •Represent the organization to regulatory authorities and external stakeholders, influencing policy discussions and negotiating approvals.
  • •Partner cross-functionally to integrate regulatory requirements into product development and business processes, conducting regulatory planning and risk assessments.
Travel: Low travel

Pay and Benefits

Salary: USD 183,000 - 291,000 annually
Perks:Paid Leave401kHsaEquity

Key Requirements

  • •8+ years of Regulatory Affairs experience in the medical device industry with people leader experience (or 6+ years with a master’s).
  • •Experience authoring Class 2 510(k) submissions (cardiology experience preferred).
  • •Strong knowledge of relevant regulations and standards, including ISO 13485 and ISO 14971, with audit/competent authority response experience.
  • •Bachelor’s or master’s degree in biomedical engineering, Business Administration, Health Sciences, Pharmaceutical, Law, or equivalent.
  • •RAC certification is preferred; excellent communication and ability to influence cross-functional stakeholders.
Experience:8+ yearsMedical device industry
Education:
Skills:CommunicationStakeholder managementRisk mitigationCross-functional collaborationContinuous improvement
Certifications:RAC

Eligibility

Work Authorization:Authorization required. Sponsorship not provided.

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