Director, Regulatory Affairs Compliance Systems & Labeling

Global Regulatory Strategy LeaderStep 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.Why You Should Apply$196,500 $245,600 base salary + 30% target bonusExecutive-level visibility with influence across global business unitsLead regulatory strategy for innovative medical device and combination productsHybrid onsite role in Lakewood, CO with global scope and 1015% international travelComprehensive medical, dental, vision, 401(k) match, wellness programs, and robust total rewardsWhat You'll Be DoingDirect global regulatory affairs and labeling strategyOversee 510(k), PMA, IDE, CE Mark, NDA/ANDA and international submissionsServe as primary interface with global regulatory authoritiesLead compliance programs including UDI and regulatory operationsPartner cross-functionally with R&D, Clinical, Quality, Legal, Manufacturing, and MarketingAct as PRRC and champion a culture of quality and complianceGuide and develop a high-performing regulatory teamAbout YouBe able to do the job as described.Deep experience with both sterile disposables and electro-mechanical devices with embedded softwareProven success representing novel technologies to regulatory authorities and securing approvalsExpertise across US, EU, and Canada regulatory frameworksExperience with drug/device combination products and PRRC responsibilities