Stephen McBlain

Stephen McBlain is a seasoned Regulatory Affairs and Quality Management System (QMS) professional with over 15 years of successful experience in the Medical Device, Pharmaceutical, Dental, Hygiene, and Cosmetic industries.

He holds a Bachelor of Science (BS) in Biology from Rutgers, The State University of New Jersey-Camden, providing him with a strong educational background to complement his practical expertise.

Throughout his career, Stephen has held key roles in various organizations, including Quality Assurance Regulatory Affairs Manager at Keystone Industries, QA/RA Management Representative at Biocoat, QA Auditor II at Charles River Laboratories, Quality Engineering Analyst at Abbott Point of Care, and Quality Systems and Compliance at MedImmune, showcasing his diversified experience.

He has a deep understanding of FDA, cGMP, ISO, MDD/MDR regulations and has effectively applied this knowledge to drive compliance and quality within the companies he has worked for.

Stephen McBlain's expertise spans across regulatory affairs, quality management systems, and compliance, making him a valuable asset to organizations in highly regulated industries.

With a track record of success in ensuring adherence to regulations and implementing effective QMS practices, Stephen possesses the skills and knowledge necessary to navigate complex regulatory landscapes and drive continuous improvement.

His educational background, coupled with his extensive professional experience, positions him as a proficient professional capable of delivering results and maintaining high standards in regulatory compliance and quality management.