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  1. Home
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  3. Michelle Bonn
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Michelle Bonn

MBA
CEO
Compliance Team
Country or state 
United States (New York)
Available to 
North America,
Europe,
...
City 
Buffalo
Fee 
Ask for pricing
Languages 
English
Volunteer
Yes
Timezone 
America/New_York

Personal Details

Bio

Executive life sciences leader with a history of success in transforming businesses, leading FDA regulatory initiatives, technical manufacturing projects, and driving growth in the life sciences. With a deep expertise in U.S. life science regulatory compliance, Michelle has built, acquired, and sold multiple businesses - never shying away from the tough decisions that keep companies afloat and profitable. As A CEO, Michelle has led large sales initiatives, rebranding programs, managed highly technical teams, increased profit margins and led M&A integrations. Whether it’s navigating FDA 510(k) submissions, orchestrating corporate turnarounds, or negotiating international partnerships, she brings a unique mix of strategic vision, operational execution, corporate financial responsibility and life science regulatory expertise.

Current position (1)

CEO

Compliance Team

Degrees (2)
MBA - Business Adminstation
Medaille University
2001 to 2004
Clinical Psychology
University at Buffalo
1990 to 1993

Presentations

Presentations (3)
FDA oversight for 3D-printed, medical device implants

This was a continuing education course for Attorneys at Phillips Lytle law firm in Buffalo, NY.

The information discussed FDA regulatory requirements along with Intellectual property needs for new medical technology.

Building your Medical Device Ecosystem for successful sales

Strategies for designing, funding, and launching new medical devices in the U.S. market. A special emphasis was placed on US FDA requirements.

Changes to the European Union Medical Device Regulations

This presentation discussed new clinical and regulatory requirements necessary to introduce, manufacture and sell medical devices throughout Europe under the MDR - Medical Device Regulations.

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Books & Articles (2)

How Medical Device Companies Limit Enforcement and Legal Risks
Compliance Team Articles - Medical Device and Pharma. Articles are based on information that I can speak about

Expertise (9)

Healthcare
Manufacturing
Science
Business
Medical Device Regulatory Compliance Regulatory Affairs regulatory agency interaction FDA

Clients

GSK
Merk
Curium Pharmaceuticals
Milipore Sigma
NOVAIR
Virbac Animal Pharmaceuticals
McKesson

Awards & certifications (4)

GroundBreaker Entrepreneur Award
Life Sciences NY
2021
Compliance Team Corporate Pitch Competition
Diversity Alliance for Science
2023
Woman of Influence
Buffalo Business First
2009
Entrepreneur Award
YWCA
2008
Recommendations
Why choose me? 

Business and technical acumen, dynamic presenter, FDA regulatory expert, successful entrepreneur.

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