What are the responsibilities and job description for the Director, Regulatory Affairs (Medical Devices) position at System One?
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
Ideal Background
We’re seeking a regulatory executive who combines strategic vision with operational depth.
Required Experience:
Leadership Profile
Successful candidates will demonstrate:
Additional Details
Ref: #568-Clinical
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.
- 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.
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.
- 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.
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.
- Hybrid schedule (Denver metro required).
- 10–15% international travel.
- Occasional off-hours engagement consistent with executive-level responsibilities.
Ref: #568-Clinical