Pratyesh Somani

Experience

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  Sahajanand Medical Technologies

  Dec 2009 - Feb 2013

  * Accountable to draft State FDCA Gandhinagar various applications i.e. Additional product registration, Free Sale Certificate, Non-Conviction Certificate, Market Standing Certificate, Performance Certificate * Accountable for planning, reviewing and execution of calibration and periodic clean room validation, sterilizer and sterilization method validation* Accountable for management of Online Document Management System (DMS) and documents for ISO 9001 designed Quality Management System (QMS) * Accountable for scheduling and execution of various calibration and validation activities* Accountable to schedule and route internal audit plans* Assist Management representative in plant document managements

  • Junior Executive - Regulatory Affairs

    Jan 2013 - Feb 2013

  • Junior Executive - Quality Assurance

    Jul 2010 - Jan 2013

  • Trainee Executive - Quality Assurance

    Dec 2009 - Jun 2010
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  Sahajanand Medical Technologies

  Jul 2014 - Jan 2017

  * Accountable for product registration in MENA, LATAM and CIS countries* Accountable for product import license application preparation, submission, and follow up with CDSCO* Accountable for preparing, filing and queries closures for renewal of manufacturing license, GMP certificate, registration of notified and non-notified medical devices, technical persons and plant layout approval at State Food and Drug control administration, Gandhinagar * Accountable for clean room validation activities* Accountable to update Site Master File (SMF)* Accountable to review product artwork including information for use (IFU) per Local regulatory agency and exporting countries' regulatory agency requirements

  • Senior Executive - Regulatory Affairs

    Oct 2015 - Jan 2017

  • Senior Executive - Quality Assurance

    Jul 2014 - Oct 2015
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  USM Healthcare

  Mar 2017 - Apr 2017

  Quality Manager

  * Accountable to make quality test plans for raw materials, packaging materials, and other non-critical raw materials testings* Accountable for preparation and execution of protocols for installation qualification, operational qualification and performance qualification of laboratory instruments

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  Meril Life Sciences India Pvt Ltd

  Jun 2017 - Oct 2018

  Senior Executive - Regulatory Affairs

  * Assisted in orthopedic device 510k registration.* Accountable to prepare and periodically update orthopedic device’s risk management, clinical evaluation, literature search and appraisal reports.* Accountable to prepare and maintain Adverse Event Database for orthopedic device by means of TPLC, DAEN, SARA, MHRA, and BfArM.

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  Advanced MedTech Solutions

  Oct 2018 - Jul 2020

  Senior Executive - Quality system

  * Accountable for preparation and revision of Technical files (TCF) and Query closures for CE approval of Class III medical devices* Accountable for Manufacturing license, Test license and Import license’s application preparation and submission, Challan fees submission, and post submission query closures for Medical devices at CDSCO portal, India.* Accountable for preparation of Clinical Evaluation Report

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  Nano Therapeutics

  Jul 2020 - Mar 2023

  Associate Manager RA QA

  QA- Risk management of Class IIb and Class III Medical devices- Clinical evaluation of Class IIb and Class III Medical devices- Validation and Calibration- Internal Quality Audit- ISO 13485 QMS handlingRA- CE Certification of Class III medical devices- Overseas product registration of Class IIb and Class III Medical devices- Class C and Class D medical device licensing at CDSCO

• 

  Purple MicroPort Cardiovascular

  Mar 2023 - now

  Manager QA RA

  Responsible for managing the regulatory framework and quality assurance tasks with the assistance of a team.