Lecture : General Understanding of Medical Device Single Audit Program ( view)
Doug Reimer ┃ J&J206 views
About the Speaker
A brief history
Bachelor of Science, Natural Sciences, Muhlenberg College (Allentown, PA, USA)
Master of Science, Biology & Business Administration, Seton Hall University (South Orange, NJ, USA)
Senior Director of Regulatory Compliance for the J&J Vision segment of Johnson & Johnson, Inc. Responsible for leading the Compliance organizations for the J&J Surgical Vision and J&J Vision Care medical device businesses. These include products and equipment for laser cataract surgery, phacoemulsification, and LASIK procedures; intraocular lenses and implants, orthoviscoelastic devices (OVDs); ocular surface care devices; Acuvue brand contact lenses; and contact lens care products. The role includes assuring a comprehensive and effective compliance program for the Quality Systems (QSR/ISO 13485/GMP) of the worldwide J&J Vision sites to local, national, international, and J&J corporate requirements. Prior to J&J, began career at as a scientist performing toxicology (preclinical) research. Expanded into the Quality and Compliance field in roles that included GMP, QSR, GLP, and GCP compliance responsibilities for both pharmaceutical and medical device products for Ciba-Geigy pharmaceuticals, American Cyanamid, and Becton Dickenson. He joined J&J Vision Care as Sr. Director of Worldwide Quality Systems and Regulatory Compliance and then served as Sr. Director of Supply Chain Compliance before being appointed to his current role.
Member of Regulatory Affairs Professionals Society (RAPS), American Society for Quality (ASQ), and Society of Quality Assurance (SQA). RAC-certified (Regulatory Affairs Certification) and ASQ Certified Quality Auditor. Prior member of AdvaMed Re-Processing Technical Group and SQA Medical Devices Specialty Subsection; Past-President, Mid-Atlantic Region Society of Quality Assurance (MARSQA); former Vice-President/Director of MARSQA.
Conflict of Interest