Kurtis Hunsberger

About Kurtis Hunsberger

My passion for improving patient health and quality of life with innovative products and technologies motivates my work as an experienced regulatory affairs professional. I am a thought leader and an innovator.What I do:•Lead by example, inspire, influence, deliver exceptional results, and act with integrity•Collaborate and communicate effectively with key stakeholders•Create and execute global strategies to navigate complex regulatory pathways through all phases of the product life cycle•Excel at new product development on high visibility projects•Receive and maintain regulatory approvals•Interact directly with regulators during submission reviews and audits•Travel domestically and internationallyHighlights:•Received hundreds of global regulatory approvals throughout my career•Assessed design/process changes to products with $1B revenue•Worked in Tokyo for four months•Integrated two acquisition companies•Managed staff•Saved the company $700K per year by streamlining a process•Received awards for Excellence in Improving Regulatory Skills, Excellence in Quality Improvement and Outstanding Regulatory Achievement•Earned RACWhat I desire:•Flexibility to develop strategy and manage execution of business initiatives in a diverse, innovative, and rewarding environment•New product developmentFeedback:“Kurtis is a pleasure to work with because he delivers high-quality work on time, provides timely and helpful regulatory feedback, communicates well, and is engaged and integral part of the team. I would welcome the opportunity to work with him on future projects.” -project manager“He is calm, professional, and objective yet open to change and variable styles/approaches, as necessary.” -managerKeywords:quality, clinical trial, IDE, PMA, 510(k), NDA, design dossier, technical file, Shonin, strategy, manage, writing, combination products, device, drug, acquisition, integration, mentor, consult, travel, US, EU, international

Experience

1. Director, Regulatory Affairs

   Bracco Medical Technologies

   Apr 2025 — Present · Eden Prairie, MN, US

   Lead and develop a team of 7 direct reports, fostering a high-performance culture through coaching, feedback, and targeted development planning•Serve as a key member of leadership teams, running the business, contributing to strategic planning, and driving continuous improvement initiatives•Represent Regulatory Affairs in executive forums and cross-functional initiatives to advance regulatory excellence and ensure global compliance•Delivered Regulatory, Clinical, and Technical Writing inputs and resource forecasts for Long Range Planning (LRP), aligning functional goals with enterprise strategy•Directed RA strategy and deliverables for successful BSI MDSAP audit, ensuring regulatory compliance across multiple product families•Oversaw CE MDR certification approval for injectors and disposables•Guided successful FDA Pre-Submission meeting on Human Factors strategy•Finalized key business agreements, including contracts and consulting SOWs, to support program execution and external partnerships•Hired and onboarded Principal Regulatory Affairs Specialist, expanding team capacity and supporting succession readiness•Completed RAPS Executive Development Program to strengthen executive leadership capabilities

Education

• Western Michigan University

  BS, Biology

  1999 — 2003

• Western Michigan University

  Masters certificate, Clinical Trials Administration

  2003 — 2004

Skills

• Corrective and Preventive Action (Capa)
• Acquisition Integration
• Regulatory Affairs
• 21 Cfr
• Fda
• Product Development
• Iso 13485
• V
• Pma
• Clinical Trials
• Design Control
• Quality System
• Iso 14971
• Ce Marking
• U.s. Food and Drug Administration (Fda)
• Regulatory Submissions
• Combination Products
• Medical Devices
• Capa
• Premarket Approval (Pma)