Director, Regulatory Strategy; Medical Devices

Director of Regulatory Strategy (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.)

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.

• 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.

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

• 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.

• 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.

• 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.

• Hybrid schedule (Denver metro required).

• 10–15% international travel.

• Occasional off-hours engagement consistent with executive-level responsibilities.

: #568-Clinical

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.