Michael A. Pereira is a distinguished executive and regulatory strategist with more than 30 years of experience in the medical device, pharmaceutical, and biologics industries. His expertise lies at the intersection of quality management, regulatory compliance, operational planning, and business integration, making him a trusted advisor and leader for companies seeking to align complex quality systems with business objectives and regulatory demands.

With a career spanning startups to Fortune 50 companies, Michael has built, led, and remediated global Quality Management Systems (QMS) in accordance with FDA, EMA, ISO 13485, EU MDR 2017/745, and other international standards. His work has involved everything from consent decree remediation and 510(k) and PMA submissions to combination product development and multinational regulatory filings across Japan, Brazil, Canada, Mexico, and the EU. He is also highly skilled in the development and implementation of strategies for software validation, design controls, risk management, and human factors engineering, with particular expertise in SaMD and AI/ML technologies.

Michael’s technical acumen is complemented by a solid foundation in operational and financial management. He holds a master’s degree in Operational Planning and Management from the University of Pennsylvania—an interdisciplinary program shaped by Penn Engineering, the Wharton School, and the Carey School of Law. This combination of technical and business education enables him to translate complex regulatory and quality requirements into language and strategies that resonate across executive, engineering, and operational teams. He has become known for his unique ability to bridge silos within organizations, fostering collaboration between departments and aligning compliance efforts with core business objectives.

Over the course of his consulting career, Michael has been tapped to lead major projects for some of the most recognizable names in the healthcare and life sciences sectors. He has served as the quality and regulatory lead in divestitures, supported FDA inspections, developed global quality policies, and helped emerging companies establish their first QMS from the ground up. He frequently delivers presentations internally and externally on regulatory topics, though most of his work remains proprietary and confidential due to the sensitive nature of his engagements.

Michael has also served on several boards and advisory roles, including the NIH Advisory Board at the University of Idaho, and previously sat on the board of a construction management company. From 1990 to 1999, he served as founder and board member of his own enterprise, gaining first-hand experience in entrepreneurship and corporate governance. These roles, combined with his deep regulatory knowledge, make him an ideal candidate for board service in organizations seeking seasoned guidance on compliance strategy, risk mitigation, and quality oversight.

Now actively seeking board opportunities, Michael views board service as the natural next step in his career following decades of consulting and executive leadership. He is driven by a belief that quality and regulatory transparency must be embedded within the business model—not treated as parallel tracks. With his combination of technical rigor, business insight, and global perspective, Michael brings a rare blend of capabilities that can help organizations navigate complex regulatory landscapes while staying focused on innovation and growth.

His professional philosophy is best captured by his personal mantra:
“Quality is when the customer returns and the product does not.”

Michael is based in Salem, New Hampshire, and remains actively engaged in supporting companies operating at the front lines of healthcare innovation.

Character: Michael Pereira is a principled leader who operates with integrity, accountability, and a steadfast commitment to regulatory excellence.

Knowledge: With over 30 years of experience, Michael possesses deep expertise in FDA compliance, global regulatory strategy, and quality systems for drug, device, and biologic products.

Strategic: He consistently aligns quality and regulatory functions with broader business goals, offering strategic insight that drives both compliance and competitive advantage.

Communication: Michael excels at translating complex technical and regulatory language into actionable business terms, fostering collaboration across cross-functional teams and executive leadership.