Medical Engineering
Resume:
Pratik Chaudhari
**** ***** **** ********** **** Glendale, WI 53217
USA ******************@*****.***
http://www.linkedin.com/pub/pratik chaudhari/46/5a0/a71/en Summary:
● Seeking a Quality or Regulatory Affairs Position with 2 years of experience in Medical Device industry to support a fast growing company to progress through current challenges of Quality and Regulatory expediting product to market with compliance to all applicable global standards.
● Regulatory Affairs Experience with Class I, II and III medical devices.
● Regulatory Affairs Certification: Regulatory Affairs Certificate Medical Devices (RAPS).
● Experienced in US and OUS Regulatory Submissions and Product Registrations/Approvals.
● Master of Science in Biomedical Engineering with emphasis on Regulatory Affairs in Medical Devices/ Pharmaceutical industry.
Professional Experience:
GE Healthcare, Milwaukee Wisconsin 04/2017 Present Regulatory Affairs Specialist III
● International Product Registrations/Approvals ( LATAM, China, Canada, Japan, EU, Australia)
● Reviewed and processed Engineering Change Orders to make sure changes to the instruments followed the correct Regulatory Pathway and were well documented by writing note to files and updating the CE Tech Files.
CareFusion Inc, Vernon Hills Illinois 02/2016 11/2016 International Regulatory Affairs Analyst
● International Product Registrations/Approvals:
● Obtaining the list of documents required for product registrations/approvals in their respective countries.
● Prepared and provided the documents requested for submission to the regulatory bodies in order to complete product registrations.
● Currently working on completing product registrations in the following countries: Japan, EU
& Latin America (Mexico, Peru, Colombia, Costa Rica, Brazil, Ecuador, Argentina, El Salvador, Uruguay
● 510K Submissions: Worked with the core team in obtaining and compiling the necessary datasupporting the 510k submission. Also completed the correction activities in response to the deficiencies reported by the FDA.
Zimmer Biomet Inc, Dover Ohio 09/2015 12/2015
Regulatory Affairs Associate
● Successfully completed a comprehensive training on Zimmer products.
● Worked on to develop regulatory strategies with the core team enlisting the testing, documents and timelines for registering products in US, EU, Health Canada(CMDCAS),MDD,ISO13485.
● Assisted in compiling CE Technical Files for Class I, Class II and Class III medical devices. Maintained DHRs and DHFs and provided updates as needed.
● WWCN (Field Notifications) to assess international impacts and product changes.
● Maintains electronic and paper clinical/regulatory documentation in compliance with applicable domestic/global regulations and internal QS requirements.
● Basic Understanding of QSR/ISO (ISO 13485) Regulations, 21 CFR 820, FURLS.
● Assists in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic submissions. 1. US Submissions:
● Worked with the core team in obtaining necessary data supporting the 510(k) submission.
● Compiled 510(k) for orthopedic medical devices.
2. European Union (Class Im, IIa, IIb and III medical devices):
● Worked with the core team in obtaining necessary data supporting the CE technical file submission.
● Compiled the CE Technical Files for several orthopedic surgical instruments.
● Successfully initiated and completed the correction activities in response to the deficiencies reported by the notified body indicating product non conformities. 3. International Product Registrations/Approvals:
● Obtaining the list of documents required for product registrations/approvals in their respective countries.
● Prepared and provided the documents requested for submission to the regulatory bodies in order to complete product registrations.
● Worked on CFG (Certificate of Foreign Government), Change Notices and Customer Surveys. Maxx Orthopedics, Philadelphia Pennsylvania 06/2014 08/2014 Engineering Intern
● Evaluated Orthopedic Implants and Instruments, analyzed surgical techniques of orthopedic implants.
● Corrected, reviewed failed FDA 510k submission by reviewing and updating regulatory documentation. Agilent Technologies, Mumbai India 01/2012 02/2012 Analytical Engineer Trainee
● Troubleshooting of Analytical Instruments done at various client sites.
● Trained and exposed to various parameters working on GC, LC and UV Spectroscopy. Reliance Industries, Gadimoga India 06/2012 07/2012 Summer Intern
● Worked under a project entitled “Instrumentation in Industry”.
● Studied the process, equipment and operation of all the Instrumentation based equipments (PLC, DCS) etc.
● Assisted in fixing the problems related to instrumentation devices and also learnt how to calibrate the instruments.
Graduate Research Assistant, University Of Illinois at Chicago (UIC) (09/2014 05/2015)
● The main aim of the research was to review all the papers related to the ovarian cancer and simulate the calculations with the data obtained in order to deduce the end result.
● Results were obtained with a proper methodology used during the subject of research. Volunteer Work:
Kidney Dialysis Clinic, Mumbai India (06/2010 12/2010)
● Conducted research on the clinic operations.
● Developed a computer program for the clinic and had been helpful to the clinic by use of Patient Database, Inventory Database, Auto Conducting Medical Reports and facility to store multiple diagnoses for patients and used Microsoft Visual Basic 6.0 and Microsoft Access for this. Additional Projects:
● “Optimization of Commercial used Dental Implants by composition analysis”: The research aim was to optimize the cost of dental implants by analyzing the composition.
● “Force based model of Individual Cell Migrations with separate Attachment Sites”: This model emphasizes the forces involved in the cell motion with a very simple approach to the way cells attach to a substrate or how the cells move.
● “Role of Biomechanics on IVD Degeneration and Regenerative Therapy and biomaterials for its repair”: In this mostly the effect of Degeneration and injury on biomechanics of IVD and how to repair IVD’s using biomaterials.
● “Advanced Object Sorting using PLC”: The goal of the project was to sort the objects on the basis ofweight, color, metallic and non metallic and various other quality parameters which are done in many industries globally.
Technical Skills:
● FDA 510k Submissions: Reviewed (FMEA, Design Controls (21CFR 920:30), Risk Management (ISO 14971), ISO 13485, GMP, CAPA and Validation processes, Microsoft Office.
● Other: eCTD, ISI Toolbox, Bookmark, eCTD express, Hyper linking, DMF. Course Work:
● Biomedical Imaging, Cellular Biomechanics, Biomechanics, Mechanics of Human Spine, FDA AND ISO Regulation of Medical Devices, Seminar in Bioengineering, Biomaterials, Intro to Applied Optimization, Independent Study, Controlled Drug Delivery.
Awards and Honors:
● Regulatory Affairs Certification: Regulatory Affairs Certificate Medical Devices (RAPS).
● Member of RAPS ( Regulatory Affairs Professional Society)( On going Membership).
● UIC Intramurals Indoor Cricket Spring ’15 Champions. During the whole season took the role of captaincy for my team with keeping leadership skills and positive approach among all the players.
● Certificate of Appreciation for Successful Performance in “ALL INDIA OPEN MATHEMATICS SCHOLARSHIP EXAMINATION”.
● National Talent Search Examination (NTSE) Includes Mathematics and Science section, selectedfor last level (Level1 and Level2 cleared). Education:
● Masters in Bioengineering, University of Illinois at Chicago Graduation: Dec 2015.
● Bachelors in Instrumentation Engineering, Vivekanand Education Society Institute of Technology (VESIT, Mumbai) (First Class) Graduated: Aug 2013. References:
● Available upon request
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