Albert Rego, Ph.D.
Principal, Regulatory Affairs and Quality Assurance
Albert Rego, Ph.D. is a scientific consultant to the regulated industries, with over thirty years of experience in the pharmaceutical and medical device industries. Areas of specialization are in the national and international regulatory aspects of the scientific testing requirements for chemical, biological, and sterilization technologies. He has experience in performing, directing, and designing, and evaluating clinical and non-clinical studies for pharmaceuticals and medical devices. Selective expertise includes chemical stability testing, medical device evaluations, statistical design and interpretation, regulatory submissions, chemical hygiene plans, analytical chemistry methodologies, and sterilization validation.
Albert Rego, Ph.D. is the Official Correspondent and author of numerous 510(k) applications with successful Substantial Equivalence (SE) Clearances; including devices ranging from software driven active devices to cardiovascular devices and combination products with antimicrobial properties. Post Clearance support for sponsors includes Quality System audits, audit preparation, and participation in competent authority audits both domestically and internationally (Europe, South East Asia, Australia)
Albert Rego, Ph.D. has been involved as the Official Correspondent and Author of full PMA applications and PMA supplements for Class III critical devices, including authoring virtually all sections PMA applications.