Director, Regulatory Strategy (Medical Devices)
System One, Denver, Colorado, United States, 80285
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.)
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
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.
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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
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.
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