As an Executive in Regulatory and Quality in the Medical Device industry, Mr. Michael Pereira has generated documentation for medical devices and combination products for submission to both international and domestic regulatory agencies. Mr. Pereira uses his background in medical device operations/manufacturing and regulatory affairs to provide expert insight on the design, development and deployment of medical device products to comply with the appropriate regulations, standards and guidelines for safe and effective marketing and sale.
Mr. Pereira began his career at Princeton University as a staff engineer on the Research and Development Project under the Department of Energy known as TFTR, the Tokamak Fusion Test Reactor. He held various positions as Manager of the high energy coil shop, and finally as the Chief Operating Engineer for the Reactor during operations.
He has held both Global and Local positions as Vice President of Quality and Regulatory where he both established and remediated Quality Systems and Regulatory Systems to comply with 21 CFR 800 (appropriate parts) and ISO 13485, domestically and internationally.
Mr. Pereira has submitted multiple 510(k) submissions, including IDEs, and led face-to-face meetings with the FDA in Washington DC. He has developed the strategies for executing device product clearances in multiple countries, including but not limited to Europe, China, Brazil, Central America, and Canada. He has led and architected the strategies for remediation programs for device products and developed the strategies for the lifecycle of regulated products. Mr. Pereira has submitted multiple site Establishment Registrations, participated and lead cyclical FDA Inspections, both domestic and internationally and remediated post inspections observations, warning letters and consent decrees.
Mr. Pereira has built and remediated medical device products, from design controls and essential outputs, design verification/validation, design transfer, supply chain management, and production and process controls for internal and external builds to final acceptance criteria/ final acceptance for the safe and effective marketing of a device.
He has owned and operated a device with high water content, electron beam cross-linking, and aqueous polymer hydrogels used for wound care, medical diagnostics, transdermal drug delivery, and cosmetics.
Mr. Pereira has spent extensive time living in Japan and fulfilling a global Quality/Regulatory role in the endoscopic industry. He has travelled for business through Europe, South and Central America and Canada.
Mr. Pereira received his Bachelor’s of Science Degree in Mechanical Engineering from Marquette University and a Master of Science from the University of Pennsylvania with an area of concentration in Operational/Planning and Management.