Boston Biomedical Associates Announces Senior Regulatory Appointment

Boston Biomedical Associates Announces Senior Regulatory Appointment

Marlborough, MA – Boston Biomedical Associates (BBA), a strategic clinical and regulatory consultancy and full-service contract research organization (CRO) serving the medical device and biopharmaceutical industries, today announced an appointments to the company’s senior regulatory team.

Mary LeGraw has been appointed to the position of Senior Regulatory Consultant at BBA.  Ms. LeGraw, who has more than 23 years of experience in medical device regulatory affairs, will join the Consulting Services group at BBA.

“Mary’s proven industry track record and regulatory expertise make her an excellent addition to the team at BBA,” said Lauren Baker, President and CEO. “Medical device and biopharmaceutical Sponsors are increasingly reliant on strategic regulatory advice from CROs.  Mary’s appointment reflects our ongoing commitment to leverage global industry expertise, and advance our clients’ unique medical products through an ever changing, and expanding regulatory landscape,” Baker remarked.

“Joining the team at BBA provides me the opportunity to bring my experiences, and perspectives to the team at BBA.  Working with the project teams for our current and future clients, I am certain we can define the most appropriate and efficient path of meeting the regulatory requirements,” said Mary LeGraw. “I am excited to join the Consulting Services team at BBA and leverage my experience to help our clients find innovative, and straight forward regulatory strategies and solutions to advance their product through the regulatory review process,” she added.

Prior to joining BBA in 2015, Ms. LeGraw served as the VP of Global Regulatory Affairs for GI Dynamics, and in progressive regulatory roles for over 10 years at Tepha, Inc.  In addition she has worked with OmniSonics Medical Technologies, Mitek Products (Ethicon, a J&J Company), and Boston Scientific. Some of the products she has worked on includes: bioresorbable polymer made from rDNA technology for bone & tissue repair, acoustic energy for vascular occlusive disease, various medical devices for sports medicine & reconstruction surgery, interventional neuroradiology and cardiovascular devices.

Mack Rubley


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