Oscar Sanchez

Oscar Sanchez is a seasoned Quality and Regulatory Affairs Executive with expertise in Drug Product and Medical Devices.

With over 25 years of experience, Oscar specializes in turnarounds, reengineering, and product development within the medical device industry.

He is known for achieving significant reductions in recalls and quality defects, increased production yields, and successful product launches.

Oscar excels in establishing effective Quality and Regulatory systems that meet global standards, resulting in an outstanding FDA inspection record.

He has strong relationships with FDA representatives and a history of obtaining regulatory approvals for new products, including PMA's and 510K/PMA approvals.

His skills include Clinical Quality Assurance, Process Validation, Design Validation, and building strong Quality Teams.

Oscar's expertise extends to Best Practices, Regulatory Compliance, Quality Systems, Risk Analysis, GMP, Supply Chain, and various regulations in Pharmaceuticals, Medical Devices, Nutritional Supplements, and Cosmetics.

He holds a Bachelor's degree in Science with concentrations in Mechanical and Nuclear Engineering.

Oscar has held leadership positions at reputable organizations like Reata Pharmaceuticals, AMAG Pharmaceuticals, AMRI, Getinge, Novartis Pharmaceuticals, GE Healthcare, Integra LifeSciences, Becton Dickinson, Welch Allyn, Cordis Johnson & Johnson, Boston Scientific, and in the US Navy.