Mutahar Shamsi

Mutahar Shamsi has a diverse work experience spanning over several decades. Mutahar is currently working as the Director of Quality Compliance at Sage Therapeutics since May 2023. Prior to this, they worked at Covington & Burling LLP as a Senior Advisor for Medical Devices and Diagnostics from September 2019 to May 2023. In this role, they focused on evaluating quality operations and recommending improvements for effective performance, as well as conducting due diligence assessments of targets' quality systems for mergers and acquisitions.

Before their role at Covington & Burling LLP, Shamsi worked at Deloitte as a Specialist Leader for Medical Device and Pharmaceutical Quality from October 2015 to July 2019. Mutahar played a crucial role in formulating and executing FDA regulatory approaches and provided insights to support companies globally in achieving "Quality beyond Compliance."

Shamsi's extensive regulatory experience started at FDA, where they held multiple roles over the years. Mutahar served as the District Director for New England from October 2010 to October 2015 and was responsible for managing regional program planning and policy formulation. Mutahar also served as the Director of Compliance Branch and played a key role in executing compliance actions using advisory and judicial tools.

Other roles Shamsi held at FDA include Supervisory Investigator, District Medical Device Investigator Specialist, Compliance Officer, Device Pre-Approval Manager/Investigator, Investigator, and Assistant to the Director for Management Information Systems. These roles showcased their expertise in various aspects of regulatory compliance and enforcement.

Shamsi's career in the healthcare and regulatory field began in 1985 when they worked as an Engineering Analyst at FDA. Overall, their work experience highlights their extensive knowledge and expertise in quality compliance, regulatory affairs, and the medical devices industry.

Mutahar Shamsi completed their Bachelor of Science (BSc) in Biomedical/Medical Engineering from Boston University between 1981 and 1985. Mutahar then pursued a Master of Science (M.Sc.) in Electrical and Electronics Engineering at Boston University from 1985 to 1988. Later, they obtained another Master of Science (M.Sc.) degree in Computer Science from the University of Massachusetts Lowell between 1994 and 1995. In addition to their academic qualifications, Mutahar Shamsi obtained a certification as an FDA certified Level II Investigator and Medical Device Certification Performance Auditor from the FDA in January 2001.