Gina M Nagvajara

Gina M Nagvajara, PhD, has a diverse work experience in the medical device industry. Gina M is currently the Vice President of Regulatory and Quality at TELA Bio since August 2022. Prior to this, they worked as the Director of Regulatory Affairs at Prosidyan Inc. from October 2019 to June 2022.

Dr. Nagvajara also has extensive experience as the owner and Principal Consultant at SpiralMed Device Consulting, LLC, specializing in regulatory affairs consulting, clinical study auditing, R&D, preclinical testing, ISO 10993 biocompatibility testing, and patent law for the medical device industry. Gina M worked in this role from May 2012 to October 2019. Gina M was also contracted as a Project Manager for Innovation Unlimited, LLC from September 2018 to April 2019.

Before their consulting role, Dr. Nagvajara worked at Stryker as a Principal Scientist from May 2011 to September 2014. Gina M also held multiple roles at Orthovita, including Principal Scientist, Vice President of Regulatory Affairs and Intellectual Property, Vice President of U.S. Regulatory Affairs, Research and Intellectual Property, Director of Research and Intellectual Property, Sr. Intellectual Property and Research Specialist, and Sr. Product Development Specialist. During their time at Orthovita, they led global regulatory strategies and submissions, obtained FDA clearances and approvals for various medical device products, and was the primary contact for FDA interactions. Gina M worked at Orthovita from 1999 to 2011.

Dr. Nagvajara's early career included working as an Assistant Patent Examiner at the USPTO from July 1990 to September 1993, and as an intern through the COSTEP program at the Food and Drug Administration in 1988.

Gina M Nagvajara, PhD, obtained their A.B./B.E. degree in Engineering from Dartmouth College in 1990. Gina M then went on to complete their M.S./Ph.D. in Biomedical Engineering at Drexel University from 1993 to 1998. Gina M has also obtained several certifications throughout their career, including being a Registered U.S. Patent Agent from 1994 and completing various courses on regulatory affairs and medical device testing. In 2018, they obtained a certification on "Protecting Human Research Participants" from the NIH Office of Extramural Research.