Director Regulatory Affairs Compliance Systems Labeling

Step into a high-impact leadership role shaping global regulatory strategy for life-sustaining blood and cell technologies. My client is seeking a visionary regulatory leader to champion compliance systems, elevate global labeling strategy, and guide complex submissions that directly impact patients worldwide. This is your opportunity to influence executive decisions and drive a culture of quality across the full product lifecycle.

• $196,500 – $245,600 base salary + 30% target bonus
• Executive-level visibility with influence across global business units
• Lead regulatory strategy for innovative medical device and combination products
• Hybrid onsite role in Lakewood, CO with global scope and 10–15% international travel
• Comprehensive medical, dental, vision, 401(k) match, wellness programs, and robust total rewards

• Direct global regulatory affairs and labeling strategy
• Oversee 510(k), PMA, IDE, CE Mark, NDA/ANDA and international submissions
• Serve as primary interface with global regulatory authorities
• Lead compliance programs including UDI and regulatory operations
• Partner cross-functionally with R&D, Clinical, Quality, Legal, Manufacturing, and Marketing
• Act as PRRC and champion a culture of quality and compliance
• Guide and develop a high-performing regulatory team

• Be able to do the job as described.
• Deep experience with both sterile disposables and electro-mechanical devices with embedded software
• Proven success representing novel technologies to regulatory authorities and securing approvals
• Expertise across US, EU, and Canada regulatory frameworks
• Experience with drug/device combination products and PRRC responsibilities