Stephen Coulter, Ph.D.

General Manager

A business-focused leader heavily grounded in technology, Dr. Stephen Coulter has more than 30 years of proven success in leading product development organizations through commercialization with a focus on quality assurance and compliance excellence.

As Regulatory Compliance Associates® Inc.‘s General Manager, his responsibilities include support of medical device and combination product companies in the areas of compliance with 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, and ISO 10993; remediation of legacy products; resolution of internal and external audit findings; lifecycle management / product support / sustaining engineering; and product development.

Dr. Stephen Coulter has areas of expertise in product development, design control, technology partnerships, product lifecycle management, and acquisition analysis. He is experienced in the development of manufacturing process controls and quality limits for critical product lines and has a global background in biomedical product, medical device, combination product, over-the-counter drug, consumer product, and environmental product companies ranging in size from startups to multi-billion dollar companies. He also successfully aligned development, quality, and compliance organizations within a company to establish and sustain regulatory compliance to United States and international medical device regulations.

Steve’s regulatory affairs and quality assurance experience includes developing, strengthening, and auditing company design control, GMP, and quality systems; remediating design history files in response to internal and external reviews; providing technical input; and participating 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, 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 or processing, over-the-counter drugs, 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 multiple patent holder who has established and participated in patent committees to manage intellectual property (e.g., invention disclosures, patent applications, and product registrations) and has 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 Ph.D. in Macromolecular Science and Engineering and Organic Chemistry and a Master of Science in Chemistry from the University of Michigan. He has received numerous awards and appointments. Steve is a Palm Desert, California resident.

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