Director RA/QA Compliance
Director, RA/QA Compliance | Marlborough, MA or Arden Hills, MN (Hybrid)
I'm partnering with a global medical device organization seeking a Director, RA/QA Compliance to lead and modernize its global internal audit function. This is a newly created role focused on building a world-class, risk-based audit program, driving consistency across a global audit network, and helping position Quality and Compliance as strategic business partners rather than traditional auditors. Ideal for someone with a strong FDA, Regulatory, and/or Quality background who is excited by the opportunity to build, scale, and shape a global audit function from a strategic level.
What you'll be doing
- Lead and evolve the global internal audit strategy and framework
- Drive consistency, training, and capability development across a global network of auditors
- Partner with Quality, Regulatory, and business leaders to strengthen compliance and inspection readiness
- Identify compliance risks and implement proactive, scalable solutions
- Help shift the organization from a reactive audit model to a strategic, risk-based approach
Qualifications
- Prior FDA experience is strongly preferred
- 10+ years of relevant experience across FDA and industry environments
- Strong background across Regulatory Affairs, Quality Assurance, Compliance, or a combination of all three
- Experience leading audits, inspection readiness, and quality system compliance initiatives
- Bachelor's degree required; Advanced degree preferred
- Leadership experience is helpful but not required for the right technical expert
Location: Marlborough MA or Arden Hills MN - hybrid, 3 days onsite. Must be local or willing to relocate (relocation assistance available)
Compensation: $225K-$250K + bonus