Director, Regulatory Affairs (Medical Devices)

Director, Regulatory Affairs (Medical Devices)

Medical Device | Global Scope | Denver Metro (Hybrid)

Compensation: $195,000-$245,000 base + 30% target bonus
(Compensation aligned to experience, scope, and market benchmarks.)

The Opportunity

A well-established and growth-oriented medical device organization is seeking a strategic regulatory leader to guide global regulatory affairs and labeling strategy across a diverse product portfolio. This role offers the opportunity to shape regulatory direction at the executive level while driving product approvals, lifecycle management, and global compliance initiatives.

This is a highly visible leadership position supporting innovation from early development through commercialization and post-market compliance.

Location Requirement: Candidates must reside in the Denver metro area to support a hybrid work model.

What You'll Lead

• Define and execute global regulatory strategy aligned to business objectives.
• Provide executive-level regulatory guidance for new product introductions and existing commercial portfolios.
• Oversee global labeling strategy and ensure alignment with evolving regulatory standards.
• Serve as the primary liaison to regulatory authorities worldwide.
• Direct major submissions including 510(k), PMA, IDE, CE Mark technical documentation, and applicable pharmaceutical filings (NDA/ANDA).
• Champion compliance programs including UDI, state licensing, regulatory operations, and broader quality initiatives.
• Anticipate regulatory risks and proactively develop mitigation strategies.
• Guide cross-functional teams across R&D, Clinical, Quality, Legal, Manufacturing, and Commercial.
• Represent regulatory strategy at management reviews and executive forums.
• Lead, mentor, and develop a high-performing regulatory team.
• Monitor global regulatory trends and participate in industry engagement to proactively influence change.

Ideal Background

We're seeking a regulatory executive who combines strategic vision with operational depth.

Required Experience:

• 10+ years of progressive regulatory affairs experience within medical devices (combination product experience strongly preferred).
• Demonstrated success leading global regulatory submissions and securing approvals for complex technologies.
• Experience interacting directly with regulatory agencies in the U.S. and internationally.
• Strong background in global labeling oversight.
• 5+ years of people leadership experience, including managing senior-level professionals.
• Expertise in regulatory compliance across U.S., EU, Canada, and other international markets.

Preferred Experience:

• Experience with sterile disposables and/or electro-mechanical devices with embedded software.
• Exposure to drug/device combination products.
• Experience collaborating closely with clinical teams throughout trial phases.
• Background supporting or partnering closely with Quality Management Systems.
• Regulatory certification (e.g., RAC) is a plus.

Leadership Profile

Successful candidates will demonstrate:

• Executive-level strategic thinking with the ability to translate complex regulations into practical business solutions.
• Confidence representing innovative technologies before regulatory bodies.
• Strong influence skills across senior leadership and cross-functional stakeholders.
• The ability to build a culture of quality and regulatory excellence.
• Comfort operating in environments where regulatory pathways may require creative and forward-thinking strategy.

Additional Details

• Hybrid schedule (Denver metro required).
• 10-15% international travel.
• Occasional off-hours engagement consistent with executive-level responsibilities.

Ref: #568-Clinical