Lisa Michels J.D., M.S.O.L.Q
General Counsel & Regulatory Affairs Expert
As a corporate executive and attorney with more than 18 years’ experience institutionalizing global regulatory compliance in highly regulated markets, Lisa Michels leads Regulatory Compliance Associates® Inc.’s growing regulatory segment and legal department.
Lisa possesses extensive subject matter and technical expertise in the areas of global regulatory strategy and submissions, FDA crisis consulting related to 483s and Warning Letters, and quality management system implementation and/or improvement for the medical device and pharmaceutical industries.
She directs the initial and ongoing response strategies for FDA actions, including the development and implementation of robust work plans for quality system remediation and improvement initiatives, and provides third party oversight for quality and regulatory remediation activity.
In the past, she has held leadership roles at companies such as Oriel Stat-A-Matrix, Smith & Nephew, Baxter, and GE Healthcare, and was Principal of her own consulting firm. In one of her prior positions, Lisa designed and directed its first Global Compliance Program. Further, she developed and implemented global compliance policies/procedures, training, compliance committees, investigation, auditing, monitoring, and enforcement action.
Some of Lisa’s associations include:
- Minnesota Bar Association
- District of Columbia Bar Association
- American Bar Association (ABA)
- Association of Corporate Counsel (ACC)
- Regulatory Affairs Professional Society (RAPS)
- Women Business Leaders of the U.S. Healthcare Industry Foundation (WBL)
Lisa holds a Juris Doctorate from the University of Tulsa College of Law in Tulsa, Oklahoma; a Master of Science in Organizational Leadership & Quality from Marion College in Milwaukee, Wisconsin; and a Bachelor of Science in Sociology from the University of Wisconsin-Madison. She resides in Northern Arizona and travels wherever she is needed.