Regulatory Science, Digital Health, Clinical and Quality Subject Matter Expert
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With nearly 25 years of expertise in regulatory, clinical, and market access strategies for US and global markets, I excel in commercializing medical products across all development phases. I have held senior management roles, including Vice President and Director, overseeing global clinical research and regulatory teams. As an accomplished regulatory affairs leader, I have successfully brought medical devices to market, guiding them from viability through design, verification, and validation to global regulatory approvals.
I streamline procedures, implement best practices, and lead high-performing teams. I frequently lecture on regulatory aspects of the medical device product commercialization lifecycle, covering both US and international perspectives, including the FDA's risk-based classification scheme, Software Validation and Verification, Premarket Notification (510(k)), Premarket Approval (PMA), and Investigational Device Exemption (IDE) submissions. My extensive experience in medical electrical and digital health devices, particularly those incorporating artificial intelligence positions me well for this role.
I am adept at navigating the complex regulatory landscape for AI-driven healthcare solutions, ensuring compliance with US and EU software regulations, including those utilized by the FDA's Digital Health Center of Excellence. My work in digital health and AI has been instrumental in advancing innovative healthcare technologies that improve patient outcomes and streamline clinical workflows.
Resource Director of Regulatory Science and Clinical Affairs - Sterling Medical Devices dba Vantage MedTech - Moonachie, New Jersey
(2020-06 - 2024-06)
Sterling Medical Devices dba Vantage MedTech provides custom electromechanical and software solutions for the medical device industry. For more than 21 years, the Company's extensive and diverse experience in product development has helped healthcare companies bring their medical device software and hardware, electromechanical equipment, and mobile medical device apps to market. Sterling addresses the entire development process, including systems, software, electronics, mechanical, quality, compliance, and regulatory affairs.
FDA regulatory, scientific, software, clinical, and cybersecurity disciplines. In addition to coordinating the team's services, advises developers of new digital health products seeking FDA approval through the de novo process, 510(k) process, and even in tandem with drug products.
Founder and CEO - Britton Medical Consultancy LLC (fka Hetrick Medical Device Consulting LLC)
(2010-01)
Chief Compliance Officer/VP of Regulatory and Clinical Affairs - Boulder iQ – Innovation to Quality
(2015-08 - 2020-06)
Regulatory Compliance Director - Prescott's Inc.
(2015-07 - 2024-12)
Scientific Product Development Research Reviewer - Cancer Prevention and Research Institute of Texas (CPRIT)
(2014-10)
Director of Regulatory and Quality Affairs - Kestrel Labs, Inc.
(2006-08 - 2021-12)
Regulatory Consultant - CardioNXT, Inc.
(2019-08 - 2021-08)
Senior Consultant/Trainer - Oriel STAT A MATRIX
(2018-03 - 2019-03)
Senior Consultant, Global Regulatory Affairs - Emergo Global Consulting LLC, a UL Company
(2012-01 - 2018-01)
Advisory Board Member | Women in Leadership - University of Colorado, Colorado Springs
(2024-03)
Master of Science - Advanced Biotechnology - Regulatory Science - The Johns Hopkins University
Degree - Dentistry - The University of Colorado Health Science Center School
Bachelor of Science - Biology - Pacific Lutheran University
