Karin A. Hughes
Senior Vice President, Global Regulatory & Quality at Beaufort CRO | Executive Regulatory Strategy for Medical Devices & IVD | Partnering with Innovators from Development Through Approval | Board Member | Speaker
- Role
- Senior Vice President, Global Regulatory and Quality at Beaufort Cro
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
About Karin A. Hughes
As a senior regulatory affairs executive, I lead and advise on global regulatory strategy for innovative medical devices and in vitro diagnostics, aligning regulatory pathways with business objectives to advance product development and commercialization. My experience includes supporting pharmaceutical–diagnostic co-development programs, including companion diagnostics for precision medicine, and leading high-level engagements with FDA and international regulatory authorities.In my role at Beaufort CRO, I serve as a strategic regulatory consultant and advisor to pharmaceutical, medical device, and IVD sponsors, working with my team to: develop and execute global regulatory strategies, author submissions and briefing documents, and lead agency interactions to advance clinical development and marketing authorization of innovative medical devices and in vitro diagnostics; support pharmaceutical and diagnostic manufacturers (including LDT providers) in companion diagnostic co-development programs for precision medicine; advise cross-functional leadership on regulatory risk mitigation and lifecycle strategy to enable compliant innovation and global market access.As medical technologies and diagnostics continue to evolve, I remain committed to accelerating the availability of innovative solutions that improve patient care and advance precision medicine.SPECIALTIES In Vitro Diagnostics (IVD) Companion Diagnostics Regulatory Affairs Quality Assurance Product Development & Management
Experience
Senior Vice President, Global Regulatory and Quality
Jun 2020 — Present · San Diego, CA, US
I lead a seasoned team of regulatory experts who provide clients with scientific and strategic solutions aimed at successful market authorization to accelerate diagnostic commercialization and assure total product life cycle compliance.94% of our clients rate us higher than other CROs. Why? Because our partnerships with life science companies are defined by access, adaptability, and relentless accountability. Those partnerships accelerate MedTech innovations to market through agility and precision. As an agile MedTech CRO, we bring deep expertise across medical devices, in vitro diagnostics, and emerging technologies, supporting complex regulatory requirements, clinical trial execution, and data needs with clarity and discipline. We have a reputation for agility and therapeutic expertise. Our experience includes: • 20+ years of experience• 500 plus regulatory submissions including 510(k)s, PMAs, IDEs, and CE Marks• plus clinical study sites worldwide• plus clinical trials across diverse indications and testing platforms• 2,600 clinical professionals in more than 50 countries
Education
University of Virginia
Ph.D., Chemistry
Hartwick College
B.S., Chemistry
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