Director, Regulatory Affairs (Medical Devices)

Job Description

Job Description

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.