Join The Advisor Team
More

Tag: SaMD

Michael A. Pereira | Executive Leader in Regulatory, Quality, and FDA Compliance for Drug, Device, and Biologic Industries

Michael A. Pereira is a seasoned regulatory and quality executive with over three decades of experience guiding companies through the complex intersection of FDA compliance, global regulatory standards, and business operations. Known for his ability to build and remediate Quality Management Systems across diverse healthcare sectors—including drug, device, biologic, and combination products—Michael has led strategic initiatives for startups and global enterprises alike. With a rare ability to bridge technical and business teams, he brings clarity, structure, and strategic foresight to every challenge, earning a reputation as a trusted leader and advisor in highly regulated industries.

Frank Pokrop: Strategic Leader in Regulatory Affairs and Quality Assurance

Frank Pokrop is an accomplished leader in regulatory affairs and quality assurance, bringing over 15 years of expertise across medical devices, software/SaMD, capital equipment, and injectable drugs. Certified in multiple disciplines, including RAC, CQE, CQA, CSQE, and CPGP, he has successfully navigated complex global regulatory landscapes, overseeing product approvals and quality management systems for leading organizations such as Abbott, BD, CareFusion, and QuidelOrtho. Renowned for his strategic mindset and collaborative approach, Frank has led global compliance programs across 48 sites, driven cost reductions exceeding $3 million annually, and served as a trusted regulatory liaison for corporate boards and international agencies. A results-oriented executive with a passion for developing teams and achieving excellence, Frank is now seeking a senior position in regulatory affairs or quality assurance to further his impactful career.