Apurva Gokhale
About Apurva Gokhale
Apurva Gokhale is the Principal Regulatory Product Specialist at Teleflex, with extensive experience in regulatory affairs and compliance across various medical and pharmaceutical sectors.
Title and Current Role
Apurva Gokhale currently holds the role of Principal Regulatory Product Specialist at Teleflex. In this position, Apurva functions as an MDR implementation lead on-site, actively engaged in developing and establishing regulatory strategies for the transition of the current product portfolio from Medical Device Directive (MDD) to Medical Device Regulation (MDR).
Professional Career at Teleflex
Apurva Gokhale has an extensive career at Teleflex. Before becoming the Principal Regulatory Product Specialist, Apurva served as a Senior Regulatory Specialist from 2018 to 2021 and as a Regulatory Affairs Specialist from 2015 to 2018, both in Chelmsford, MA, USA. During these periods, Apurva gained substantial experience in the preparation and filing of EU Notified Body submissions, license renewal applications, and license amendments. Apurva also prepared Special and Traditional 510k submissions, working closely with the USFDA.
Previous Work Experience
Prior to Teleflex, Apurva Gokhale worked at NxStage Medical as a Regulatory Affairs Specialist from 2013 to 2015 in Lawrence, MA. Earlier roles include serving as a Regulatory Affairs Co-op at SpineFrontier in 2012 for three months in Beverly, MA, and as an Intern at Sandoz India Private Ltd. for two months in 2010.
Education and Expertise
Apurva Gokhale holds a Master's of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University, completed between 2011 and 2013. Additionally, Apurva earned a Bachelor's degree in Pharmaceutical Sciences from Bombay College of Pharmacy, graduating in 2011. Apurva is also ISO 13485:2016 Certified Lead Internal Auditor with expertise in internal auditing of process and quality system elements.
Regulatory Skills and Proficiencies
Apurva Gokhale is proficient in areas such as US (GUDID, UDI, LANSA), EU (Eudamed), and ISO labeling requirements, having successfully led labeling update projects for US and OUS geographies. Skilled in working within cross-functional teams, Apurva has collaborated with global regulatory colleagues to execute regulatory projects related to product design, manufacturing, and labeling changes. Apurva is also familiar with special designations like Orphan drug, HDE, Accelerated, and Fast track approval and is adept in using SAP ERP and Agile software systems.