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Regulatory Affairs Associate Specialist

Leesburg, VA
June 22, 2018

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470-***-**** h ttps:// Career Profile

An aspiring biomedical engineer passionate about developing innovative solutions to existing problems in healthcare that ensure patient safety and lead to improvement in the quality of patient care. Skills Summary

Professional Skills: Verbal and written communication, attention to detail, adaptability, decision-making, self-starter, interpersonal, collaboration, critical thinking, time management, multitasking, problem-solving. Technical Skills: Microsoft skills,Adobe Acrobat, C++, C, Matlab, SAS, Minitab, LabVIEW. Education

Master of Biomedical Innovation and Development (MBID) Georgia Institute of Technology, Atlanta, Georgia, GPA: 3.62 July 2017 B.E. in Medical Electronics

B.M.S. College of Engineering, Bangalore, India, CGPA: 9.03/10 (Equivalent to 4.0 GPA) June 2016 Experience

K2M, Inc., Associate Regulatory Affairs Specialist August 2017- Present.

● Strategising, coordinating and conducting timely registrations, renewals and amendments in OUS markets: Australia, Costa Rica, EU, Japan, MEA (Saudi Arabia, Kuwait, and Israel), New Zealand, Serbia and Taiwan.

● Collaborating with internal and external stakeholders to create effective strategies in order to support product demand in US/OUS countries and meet regulatory requirements in US and OUS countries in order to ensure compliance to vigilance, market approval and quality requirements.

● Supporting documentation requirements for regulatory bodies and other stakeholders. (Legal documents, proprietary product information, sales info etc.)

● Performing Post-Market Surveillance activities including adverse event reporting in US and OUS markets and conducting OUS recalls(FSCA/FSN). Performing trend analyses for various product lines and providing vigilance history as required. Georgia Tech, Vannberg Lab, Graduate Research Assistant(GRA) October 2016 – June 2017

● Worked in a cross-functional team on the commercial/business aspects of an ovarian cancer drug prediction model by performing analysis of existing competitive landscape to improve the quality of the model that would make it a better fit for industrial use.

● Involved in creating a protocol, workflow and business model for cancer detection using a novel technique. GE Healthcare, Bangalore, India, Operations Management Leadership Program(OMLP) Intern June-July 2015

● Worked on developing a system that would help in tracking and optimizing tools and equipment in the X-RAY GEN Engineering Lab for two months.

● Implemented a workflow using GE Support Central Tool & Microsoft Excel for issuing, tracking and returning the tools and equipment. Presented a validated working model of the tool for future implications. Academic Projects

Georgia Institute of Technology, Chronic Total Occlusion August 2016 – June 2017

● Worked in a multidisciplinary team to develop an innovative and feasible solution for treating chronic total occlusions in the coronary arteries.

● Developed a clinical and business case by understanding the current market for interventional devices (IP, competitive landscape, interactions with physicians etc.) along with providing a Regulatory and Reimbursement Strategy.

● Designed a functional prototype by performing key design activities like DIOVV, DFMEA, Risk analysis and animal testing. Georgia Institute of Technology, Medical Device Regulatory Requirements May 2017 – June 2017

● Deep understanding of constructing and writing effective presentations to FDA, Classification Regulations and Regulatory Strategy in the US.

● Research assignments on a wide category of medical devices involving submission of Demo sample 510(k) and De Novo 510(k), IDE, Modular (SSED) and Full PMA.

● Designed Bench testing, labeling, packaging, animal and clinical testing plans etc. based on standards like I SO 10993, 14971, 13485, 60601-1 series and GMP Practices.

GE Healthcare, Bangalore, Enhancing efficiency of X-Ray Generator September 2015 – May 2016

● Designed a user interface for communication with an X-Ray Generator using Visual Studio C++ and RS-232 serial communication to command the X-Ray generator for various exposure parameters and control it, using feedback and error commands.

● Developed a functional prototype that could be used in performing testing of the X-Ray generators in the development stage. Activities

Mentee in the Student Alumni Association - GT Mentor Jackets, Member of the BMSCE Alumni Association – assist students in education abroad, Volunteer in University cultural fest, 2012, Team Leader in the master’s Project.

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