SAP
Jatin Rawat
GQRA Specialist
Kotdwāra
Summary
Analytical and detail-oriented professional focused on making sure products meet all relevant domestic and international regulatory requirements. Methodical and objective with good judgment and sound critical thinking and problem-solving abilities. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
9
9
years of professional experience
2
2
years of post-secondary education
2
2
Certifications
Work History
Regulatory Affairs Specialist
Agilent Technologies International Pvt. Ltd.
04.2021 - Current
- Manage, Plan and execute the preparation, review and submission of dossiers for product registrations, import licenses and other approvals from regulatory agencies thereby supporting the business units and supply chain management in compliance with regulatory requirements in India
- Submission of SCIP (Substances of concern in products) Notifications (established under Waste Framework Directive)
- Coordination with global regulatory teams, local BU & other functions, for regulatory strategies and all documentation support required for regulatory submissions in India
- Work closely with consultant and cross functional teams to implement the Obligations as per Plastic, Battery and E-Waste Management Rules
- Environmental reporting EU with respect to RoHS & REACH
- Submit and track registration/ re-registration applications with the authorities
- Understanding & interpretation of law & the local regulatory requirement and implementing same in submission with compliance
- Close monitoring of any changes in local & global regulations and communicating same within the department and respecting & following all SOP / system implemented within the department and organization
- Ensure business continuity through regulatory fillings, obtaining regulatory approvals and continuously ensuring regulatory compliance
- Also ensure continuous implementation of Quality Management System in India
- Development, Implementation and maintenance of regulatory systems pertaining to regulatory document management (SOP's, archival, trackers and systems) within the department and organization
Sr. QA Executive
Medico Electrodes International Pvt. Ltd.
06.2018 - 03.2021
- Review and closure of Queries as per 21 CFR 820.198, EU MDR and MDR 17 standards established within organization.
- Manage, plan and coordinate the preparation, review, and submission of dossiers for product registration for Filings on SUGAM PORTAL including registration, re-registration, endorsements, import license, and test license applications.
- Reviews device labelling and analyses and recommends appropriate changes. Understands and Monitors changes in the regulatory environment, evaluates impact, and communicates to interested
parties. Manage registration projects (such as name changes, legal manufacturer changes, manufacturing site changes). - Preparation of SOPs for all the departments in Internal as well as External Audit BSI Surveillance audit process formation and updating along with the SOP's format changing of various departments.
- Handling of customer complaints and Preparation of COC & COAs.
- Confirm complaint condition and determine corrective action (including CAPA as needed).
QA Executive
Parekh Integrated Services Pvt Ltd
04.2017 - 05.2018
- Plan, execute internal audits, warehouse audit to make certain the compliance as per standards governed (ISO 13485, ISO 9001).
- Provide training to the warehouse employees including warehouse In charge.
- Responsible for gathering, compiling, and managing quality related data like CAPA, NC, Change control, Temperature Graph etc for all north branches.
- Participate and Represent Quality in External Audits such as BSI surveillance/ transition audit .
IPQA Officer
J Mitra and Co. Pvt. Ltd.
07.2015 - 03.2017
- Responsible for In-process activities and Line Clearance of various activities
- Managed over 30 BMRs & BPRs reviews per day
- Participation in Internal & External audits.
Education
M.Sc. in Biotechnology -
Sardar Bhagwan Singh Post Graduate Institute of Biomedical Sciences and Research
09.2013 - 05.2015
Skills
Regulatory Submissions
undefinedDetails
Near Manpur Chauraha, Shivpur, Kotdwāra, 246149, India, +9178381 80433, jatinrawat993@gmail.com, 09/24/93, Kotdwara, Uttarakhand, Indian
Accomplishments
1. Received Award for being Instrumental in developing a SCIP notification strategy.
2. Received certificate of Recognition for Teamwork (Implementation of Plastic waste management in India working with cross- functional disciplines.
Software
Certification
Internal Auditor- ISO 13485
Interests
Dancing
Travelling
Vieo Creating
Playing Chess
Timeline
Regulatory Affairs Specialist
Agilent Technologies International Pvt. Ltd.
04.2021 - Current
Sr. QA Executive
Medico Electrodes International Pvt. Ltd.
06.2018 - 03.2021
Internal Auditor- ISO 13485
10-2017
Internal Auditor- ISO 9001
10-2017
QA Executive
Parekh Integrated Services Pvt Ltd
04.2017 - 05.2018
IPQA Officer
J Mitra and Co. Pvt. Ltd.
07.2015 - 03.2017
M.Sc. in Biotechnology -
Sardar Bhagwan Singh Post Graduate Institute of Biomedical Sciences and Research
09.2013 - 05.2015
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