Michelle Lewis is a Regulatory Affairs Manager at Proxima Clinical Research, a contract research organization that serves the emerging drug and medical device industries.
At Proxima, she will work on various medical device and drug product consulting projects and submissions across all stages of development. Prior to joining the Proxima team, Michelle served as the Director of Accreditation at the premier standard setting body, non-profit, scientific, and educational organization, where she managed the accreditation program. She has also served in additional quality, regulatory affairs, and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.
She has been an active regulatory and quality systems auditor for more than 20 years working in a variety of industries including biologics, drugs, medical devices, and HCT/P’s as a supplier auditor, internal auditor, and consultant. Michelle has written content and managed complex quality and regulatory systems for multiple companies through her more than 20 years in industry.
After finishing a BA in Psychology, Michelle's direct industry expertise began while working for Baxter International as a Quality Management Representative in the BioScience division. Through her time at Baxter, Synthes USA, AlloSource, and AATB she gained a wealth of 1st, 2nd, and 3rd party regulatory and quality experience.
University of North Dakota: Psychology, B.A.
American Society for Quality: Devices, biologics, drugs, CMDA
Regulatory Affairs Professional Society: US Devices, biologics, drugs, RAC
Proxima Clinical Research, Inc., Houston, Texas
Regulatory Affairs Manager
Periodic, Inc., Fernandina Beach, Florida
Principal Consultant
American Association of Tissue Banks, McLean, Virginia
Director of Accreditation
AlloSource, Centennial, Colorado
Senior QA Auditor - Analyst
Spectranetics Inc., Colorado Springs, Colorado
Senior Internal Auditor
Synthes, USA, Monument, Colorado
Regulatory Compliance Auditor
Baxter International Inc., Ames, Iowa
Center Manager
Baxter International Inc., Ames, Iowa
Quality Management Representative
Ms. Lewis has played an important role in the development of the following medical products:
- HCT/Ps for transplantation
- HCT/Ps for non-transplant
- Medical Device- bone putty
- Medical Device - orthopedic implants
- Medical Device- Vascular interventions
AATB, American Association of Tissue Banks
- Shipping and Packaging Validation Workgroup Member
- Auditor Course Development Author
- Standards Committee Member
- Accreditation Committee Member
