Meetkumar Lad
Navsari
Summary
Regulatory Affairs Coordinator with extensive expertise in global regulatory requirements and procedures in the medical device industry. Skilled in documentation coordination, submission preparation, and tracking compliance regulations. Proven project management capabilities and strong communication skills contribute to successful team leadership and process improvements. Committed to enhancing operational efficiency while ensuring adherence to all regulatory standards.
Overview
6
6
years of professional experience
Work History
Sr. Coordinator - Regulatory Affairs
Chetan Meditech Pvt. Ltd. (Biotek Ortho)
Ahmedabad
11.2023 - Current
- Manage the preparation and upkeep of regulatory documents for Class IIb and Class Ir medical devices, aligned with EU MDR 2017/745 requirements.
- Oversee the preparation and submission of CDSCO medical device applications for manufacturing licenses, import permissions, post-approval changes, and import licenses.
- Participation in risk management activities within the organization and collection of PMS data, as per the defined PMS plan.
- Prepare PSUR reports as per the defined PMS Plan and applicable regulatory guidelines for Class IIb implantable medical devices.
- Draft and submit the adverse event reports to competent regulatory authorities to comply with vigilance requirements.
- Conduct internal audits of cross-functional departments, prepare the auditor notes, and suggest improvements as appropriate.
- Conduct training sessions for junior colleagues.
Engineer - QA/RA
Sahajanand Laser Technology Ltd.
Gandhinagar
10.2021 - 10.2023
- Prepared dossiers in compliance with various international regulatory standards.
- Prepared dossiers and applications for CDSCO manufacturing license approvals.
- Supported development of Clinical Evaluation Plan.
- Conducted literature review for Clinical Evaluation Report on Class III medical devices.
- Executed Post Market Surveillance (PMS) and Post Market Follow-Up (PMCF) operations.
- Created and managed PMS plans and PSUR documentation.
- Contributed to the creation of Biological Evaluation Plan & Report.
- Ensured product artwork adhered to all regulations.
- Conducted thorough reviews of clinical study documents such as protocols and reports.
- Prepared and maintained technical documentation according to European regulations, and handled query replies to notified bodies and competent authorities.
Junior Engineer - (R&D)
Sahajanand Laser Technology Ltd.
Gandhinagar
09.2020 - 09.2021
- Conducted comprehensive analysis for Clinical Evaluation projects.
- Contributed to design and development of Electroporation Device for DNA Delivery.
- Contributed to the design and development of the Smart Balloon Catheter.
- Exhaustive internet & literature search for analysis of current technologies for high-risk implants and medical devices.
- Contributed to product improvement of cardiovascular Class III medical devices
Intern
Shira Medtech Pvt. Ltd
Ahmedabad
12.2018 - 01.2019
- Developed the welding fixtures for reducing human efforts in pulse arc welding of microsurgical clamps
Education
Bachelor of Engineering - Biomedical Engineering
Government Engineering College - GTU
Gandhinagar08.2020
Higher Secondary Schooling -
Shree Shreeji English Medium School - CBSE
Bilimora04.2016
Secondary Schooling -
Shree Shreeji English Medium School - CBSE
Bilimora04.2014
Skills
- MS office
- Work Planning and Prioritization
- Document control
- Adaptability and flexibility
- Risk management
- Verbal and written communication
- Discretion and confidentiality
- Client coordination
- Multitasking and organization
- Project coordination
References
References available on request.
Timeline
Sr. Coordinator - Regulatory Affairs
Chetan Meditech Pvt. Ltd. (Biotek Ortho)
11.2023 - Current
Engineer - QA/RA
Sahajanand Laser Technology Ltd.
10.2021 - 10.2023
Junior Engineer - (R&D)
Sahajanand Laser Technology Ltd.
09.2020 - 09.2021
Intern
Shira Medtech Pvt. Ltd
12.2018 - 01.2019
Bachelor of Engineering - Biomedical Engineering
Government Engineering College - GTU
Higher Secondary Schooling -
Shree Shreeji English Medium School - CBSE
Secondary Schooling -
Shree Shreeji English Medium School - CBSE
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