Charmaine Sutton portrait

Charmaine Sutton

Adjunct Faculty
Office
OSS 228
Hours
By appointment
Phone
651-962-5750
Mail
University of St. Thomas
Mail OSS 101
2115 Summit Ave
Saint Paul MN 55105

Areas of interest and expertise:

  • US and International Medical Product Regulatory – Market Authorizations and Post-Market Experience
  • Quality Systems, Quality Engineering, Design Assurance
  • Medical Device Manufacturing Operations
  • Risk Management Systems
  • Post-Market Surveillance Systems
  • Strategic thinking, leadership, teaching, mentoring

Career Highlights:

Charmaine Sutton is principal consultant and co-founder of The Tamarack Group, an association of consultants assisting developers and manufacturers of medical devices, diagnostics, pharmaceuticals, biologics and combination products gain market access and comply with US, EU and worldwide regulatory requirements.

Ms. Sutton served as Sr. Vice President, Regulatory & Quality Assurance and Senior Vice President of Operations at Vascular Solutions (Maple Grove, MN) and served on the VSI Board of Directors. She has proven expertise overseeing product and process development, ISO 13485 and US FDA QSR quality assurance and quality systems, product risk management, regulatory market authorizations, supply chain management and manufacturing operations, and post-market quality and regulatory support. Prior to co-founding The Tamarack Group, Ms. Sutton held Director and VP level Engineering, Regulatory, Quality and Clinical positions in start-up companies, and was a research scientist in the laser fusion program at Lawrence Livermore National Laboratory. From 2006-2011 Ms. Sutton was an adjunct instructor for the Regulatory Affairs and Services graduate program at St. Cloud State University.

Education and Professional Affiliations:

Bachelor of Science - Applied Physics / Quantum Optics, University of California - Davis
Regulatory Affairs Certification (RAC)

Fall 2017 Courses

Fall 2017 Courses
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J-Term 2018 Courses

J-Term 2018 Courses
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Spring 2018 Courses

Spring 2018 Courses
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