Director, Quality & Regulatory- Mergers & Acquisitions; M&A

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

The Director, Quality & Regulatory M&A is an enterprise Q&R leader for M&A activities and primary interface to deal teams, providing end-to-end leadership across the transaction lifecycle, with a focus on complex divestitures, carve-outs, and separations. The role is accountable for defining and executing QMS separation and integration strategies, ensuring continuity of compliance and regulatory obligations from due diligence through post-close.

The Director also manages quality and regulatory risks, partnering cross-functionally to deliver compliant, timely outcomes while maintaining QMS integrity and business continuity.

Your Role:

• Lead end-to-end Quality & Regulatory (Q&R) 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 development of Quality Separation Charters, detailed execution plans, and multi-year transition roadmaps.
• Lead complex, cross-functional transaction initiatives involving multiple legal entities, external partners, and regulatory stakeholders, ensuring delivery against time-sensitive milestones and deal objectives.
• Develop and govern Transition Service Level Agreements (TSLAs) and associated operating models, including leadership of transition programs supporting regulatory commitments such as Consent Decree exit where applicable.
• Establish and maintain Master Quality Agreements between Remain Co and New Co to clearly define ownership of QMS processes, product quality, and regulatory responsibilities.
• Partner with Regulatory Affairs, Legal, and external authorities (e.g., FDA, notified bodies) to define regulatory strategies, manage correspondence, and ensure compliant execution of transaction-related activities.
• Ensure proactive management of quality, compliance, and regulatory risks, including oversight of activities related to external audit findings, FDA 483 observations, consent decree commitments, and internal quality system requirements.
• Lead QMS transition and co-ownership activities during divestitures, including certification strategy, renewal, transfer, and ongoing maintenance of applicable QMS certifications.
• Develop and lead execution of product quality and regulatory transition strategies, including migration of responsibilities, oversight of design changes, and continuity of product lifecycle management.
• Drive Day 1 readiness and Day 2 execution, partnering with cross-functional teams (including Process & System Excellence) to ensure operational continuity and successful separation.
• Provide oversight of product quality performance during transition, including monitoring of complaints, recalls, field actions, and adverse event reporting to ensure compliance and patient safety.
• Partner with manufacturing sites, supply chain, and supplier quality organizations to ensure alignment on QMS processes, procedures, and controls supporting ongoing operations during and after separation.
• Ensure effective execution of QMS governance activities under TSLA frameworks, including internal audits, management reviews, quality data monitoring, and support to global market organizations.
• Support financial and operational planning for transactions, including assessment of stranded costs, resource requirements, and impacts to Annual Operating Plan (AOP).
• Provide governance, reporting, and executive updates to senior leadership and steering committees, including tracking of key risks, milestones, and performance indicators.
• Ensure successful transition and exit of transition services, including full transfer of Q&R responsibilities and retirement of TSLA obligations prior to completion of Day 2.

You're the right fit if:

• You have a minimum of 15+ years' experience in FDA regulated global medical device environments (Class III products/devices preferred) with demonstrated experience/expertise in cross-functional Program leadership/management, focused on Quality/regulatory compliance, change management and M&A within global/matrixed medical device organizations.
• You have extensive leadership experience in various aspects of Quality, such as M&A, design quality, quality systems, post market surveillance and internal / external audit representation for multi-site business in a large multi-national company
• You're experienced in utilizing Quality system metrics/KPI's to drive high performance.
• You have detailed knowledge of global medical device regulations, requirements, and standards, such as FDA, ISO
  13485, ISO
  14971, EUMDR for all classifications of medical devices.
• You're very familiar with business process management frameworks including best industry practices related to QMS
• You're a highly collaborative influencer who is an effective communicator and relationship builder.
• You have a minimum of a Bachelor's degree in Quality,…