Jan Michener Whipple, based in northeastern Florida, specializes in Quality and Regulatory Compliance for Medical Devices, In-vitro Diagnostics and Combination Products. With 35+ years of experience, Jan has a comprehensive background in all aspects of global Quality requirements, Product Design, Risk Management, Supply Chain Operations, Post-Market Surveillance, Audits and Inspections, as well as enforcement response and remediation. Jan works to stay at the forefront of regulatory intelligence and industry best practices to provide pragmatic and optimized solutions for clients.
With a track record of comprehensive quality performance and improvements, Jan created J Michener Whipple & Partners, LLC in 2026 to provide Quality and Regulatory consulting services to clients globally. From 2013 through 2025, Jan was a Partner at Validant/ELIQUENT Life Sciences where she worked as a hands-on consultant, strategic advisor, and business partner. Jan’s responsibilities included serving as interim Head of Quality, leading acquisition integrations, facility start-ups, tech transfers and plant closures, preparation for agency inspections and Notified Body audits, inspection response and Warning Letter remediation, Quality Management System design and improvement, new product introductions, and implementation of the latest standards and global regulations for Medical Devices, In-Vitro Diagnostics and Combination Products.
Prior to joining Validant/ELIQUENT, Jan held roles of increasing responsibility and within Beckman Coulter Inc, including management positions in Q.A., Q.C., Quality Systems and Compliance, Manufacturing Engineering, Packaging & Cold Chain Process Development, Supplier Management, Logistics (Warehousing & Transportation), Warning Letter Remediation, Due Diligence, M&A Integration, Value Engineering, and serving as the Management Representative.
Jan received her Bachelor of Science degree in Mechanical Engineering from California State Polytechnic University, Pomona, and her Masters of Business Administration from California State University, Fullerton. She is a Professionally Licensed Mechanical Engineer and has completed several post-graduate and certification programs. In addition, she is actively involved in a number of technical and trade associations including RAPS, FDLI, and others in an effort to stay current with regulatory trends and industry best practices.