Stephen Coulter, Ph.D.

General Manager and Subject Matter Expert

Dr. Stephen Coulter is a business-focused leader heavily grounded in technology.  He has over 40 years of proven success in leading product development organizations (global as well as small start-up) through commercialization with a focus on quality assurance and compliance excellence.

As Regulatory Compliance Associates’® General Manager and Subject Matter Expert, his responsibilities include support for biomedical product, medical device, combination product, over-the-counter (OTC) drug, nutritional, consumer and environmental product companies in the areas of compliance with 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, and ISO 10993; development of Quality Management Systems; remediation of legacy products; resolution of internal and external audit findings; lifecycle management; product support; sustaining engineering; product development; and staff or management training.

Dr. Stephen Coulter’s areas of expertise include product development, design control, design transfer to manufacturing, technology partnerships, product lifecycle management, portfolio management and acquisition analysis.  He is experienced in the development of manufacturing process controls and quality levels for critical processes or products.  He also successfully aligned development, quality and compliance organizations within companies to establish and sustain regulatory compliance to United State and international medical device regulations.

Steve’s regulatory affairs and quality assurance experience includes preparation of design history files or technical files for regulatory submissions.  He has also participated in company advocacy efforts with federal agencies, congressional personnel, and public health groups.

His fields of technical experience include polymer synthesis:  urethanes, silicones, acrylics, rubbers (latex and synthetic), epoxies, hydrogels and biodegradables.  He also has experience with polymer processing including molding, latex dipping, extrusion, coatings and composites.  Other technical areas of expertise include surface modification methods for improved compatibility, microbicides and antibacterial treatments; natural products and herbal formulations for consumer products; and sensor development (e.g., critical care cardiac, consumer in vitro diagnostics, immunochemical and environmental monitors.)

Steve is a noted published author, exceptional presenter, and holder of multiple patents who has established and participated in patent activities (patent committees, intellectual property management), executed and managed technology assessment activities including confidentiality and licensing agreements, due diligence efforts (technical, regulatory and compliance) and technology partnership programs with entrepreneurs and academia.

Steve has a joint Ph.D. in Macromolecular Science and Engineering, and Organic Chemistry as well as a Master of Science in Chemistry from the University of Michigan.  He has received numerous awards and appointments.  Steve is a resident of Palm Desert, California.

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