Director, Quality & Regulatory- Mergers & Acquisitions (M&A)
$162,000–$288,000 year
On-site · Cambridge, Massachusetts, United States or Nashville, Tennessee, United States
Job Summary
Lead end-to-end Quality & Regulatory (Q&R) execution across M&A transactions from diligence through Day 2 transition, defining QMS separation and disentanglement strategies for divestitures/carve-outs; develop transition roadmaps, SLAs (TSLAs), and master quality agreements; partner with Regulatory Affairs, Legal, and external authorities (e.g., FDA, Notified Bodies) to ensure compliant execution of transaction-related activities; oversee quality, regulatory risks, audits, and regulatory commitments; drive Day 1 readiness and Day 2 execution with cross-functional teams, ensuring operational continuity and patient safety; this office-based role requires in-person presence at multiple U.S. locations (Cambridge, Bothell, San Diego, Plymouth, Colorado Springs, Nashville) with up to 15% travel.
Required Qualifications
- Bachelor's degree in Quality, Regulatory, Life Science, Engineering or related technical discipline (required)
- 15+ years of experience in FDA-regulated global medical device environments
- Proven cross-functional program leadership and management
- Experience with quality systems, regulatory compliance, change management, and M&A within medical devices
- Knowledge of global medical device regulations (FDA, ISO13485, ISO14971, EUMDR)
- Strong collaboration, communication, and relationship-building skills
- Master's degree/MBA strongly preferred
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