Director, Quality & Regulatory- Mergers & Acquisitions (M&A)

Philips
Nashville, San Diego, Colorado, Washington, Chicago, Minnesota, Orlando, Massachusetts
Workplace: OnsiteFull timeFunction: Quality & Regulatory (Non-Software)Experience: 15+ yearsEducation: bachelorsSkills: ["Leadership","Regulatory strategy","Stakeholder management","Risk management","Quality metrics"]

Senior-level, enterprise Quality & Regulatory leader responsible for end-to-end Q&R execution across M&A transactions, defining separation and integration strategies for QMS, managing regulatory affairs with FDA and notified bodies, and ensuring continuity of compliance through due diligence, Day 2 transition, and post-close activities. Partners across Legal, Regulatory, and manufacturing to mitigate risks, oversee audits, and drive timely regulatory commitments and product lifecycle continuity.

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Philips
Philips
3 months ago

Director, Quality & Regulatory- Mergers & Acquisitions (M&A)

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Last checked: 32 days agoStatus: Live

Job Summary

Senior-level, enterprise Quality & Regulatory leader responsible for end-to-end Q&R execution across M&A transactions, defining separation and integration strategies for QMS, managing regulatory affairs with FDA and notified bodies, and ensuring continuity of compliance through due diligence, Day 2 transition, and post-close activities. Partners across Legal, Regulatory, and manufacturing to mitigate risks, oversee audits, and drive timely regulatory commitments and product lifecycle continuity.
Location: Nashville, San Diego, Colorado, Washington, Chicago, Minnesota, Orlando, Massachusetts
Workplace: Onsite
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Director level

Key Responsibilities

  • •Lead end-to-end Quality & Regulatory execution across M&A transactions, serving as the primary interface between enterprise deal teams and the broader Q&R organization from diligence through Day 2 transition.
  • •Define and execute QMS separation and disentanglement strategies for divestitures and carve-outs, including Quality Separation Charters and multi-year transition roadmaps.
  • •Lead cross-functional transaction initiatives involving multiple legal entities, external partners, and regulatory stakeholders to meet time-sensitive milestones and deal objectives.
  • •Develop and govern Transition Service Level Agreements (TSLAs) and operating models, including regulatory commitments such as Consent Decree exits when applicable.
  • •Establish and maintain Master Quality Agreements between RemainCo and NewCo defining ownership of QMS processes, product quality, and regulatory responsibilities.
Travel: Low travel

Pay and Benefits

Perks:401kEquityPaid LeaveLearning BudgetHsa

Key Requirements

  • •Minimum of 15+ years of experience in FDA-regulated global medical device environments (Class III preferred) with cross-functional program leadership focusing on Quality/regulatory compliance, change management, and M&A within global/matrixed medical device organizations.
  • •Bachelor's degree in Quality, Regulatory, Life Science, Engineering or similar technical discipline (Master's degree/MBA strongly preferred).
  • •Extensive leadership experience in Quality areas such as M&A, design quality, quality systems, post-market surveillance, and internal/external audits across multi-site organizations.
  • •Detailed knowledge of global medical device regulations (FDA, ISO13485, ISO14971, EUMDR) for all device classifications.
  • •Strong collaboration, communication, and relationship-building skills; able to drive KPI-based performance and governance across TSLA/QMS frameworks.
Experience:15+ yearsFDA regulatedMedical devicesM&AQuality systems
Education:Bachelor's
Skills:LeadershipRegulatory strategyStakeholder managementRisk managementQuality metrics
Languages:English
Tech Stack:QMSISO13485ISO14971FDA

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