Summary
Overview
Work History
Education
Skills
Publications
Timeline
Generic

Vamshi Gaikwod

Eden Prairie,USA

Summary

Regulatory Affairs Specialist with over four years of experience in global medical device regulations, focusing on compliance, strategy, and market access for Class I, II, and III devices. Proficient in preparing international regulatory submissions for dental and orthodontic products, ensuring adherence to FDA, EU MDR, and other global standards. Demonstrated expertise in device listings, facility registrations, and technical documentation, complemented by a strong background in sterilization validation and quality assurance. Holds a master's degree in Regulatory Affairs and Services, enhancing legal insight into regulatory compliance and driving product commercialization through effective regulatory planning.

Overview

6
6
years of professional experience

Work History

Quality Engineer

Zomedica Inc.
Plymouth, Minnesota
03.2025 - Current
  • Performed QC and bench testing of veterinary diagnostic devices under GMP/GLP, supporting consistent product performance and regulatory compliance.
  • Working on companies ISO 13485, and ISO 14971 certification processes, including gap assessments, document control, and audit readiness.
  • Investigated CAPAs using Root Cause Analysis, addressing non-conformities and customer complaints with effective corrective actions.
  • Reviewed Device History Records, change controls, and validation protocols to maintain compliance with quality and regulatory standards.
  • Collaborated with R&D and manufacturing for design verification, validation, and equipment qualification, including automated instrument validation and process optimization.
  • Prepared technical documentation for EC Certification and CE marking under EU MDR/IVDR compliance.
  • Applied quality tools like FMEA and SPC, conducted data analysis (Excel, GraphPad), and managed calibration, maintenance, and inventory traceability.

Regulatory Affairs Specialist II

Solventum (3M)
Maplewood, Minnesota
09.2022 - 02.2025
  • Demonstrated expertise in navigating regulatory requirements by preparing and submitting comprehensive documentation for international regulatory approvals of dental solutions and orthodontic products, ensuring compliance with global standards and facilitating market access.
  • Accountable for delivering comprehensive documentation to facilitate product registration and approval processes.
  • Prepared and structured regulatory documents, such as 510(k) premarket notifications, to ensure compliance with FDA device approval requirements.
  • Prepared technical justifications and statements for international inquiries concerning Class I and Class II medical devices and corresponding accessories and tools.
  • Maintaining up-to-date knowledge of FDA regulations, 510(k)s, CE, quality management systems, and other relevant regulatory standards.
  • Performed gap analyses to pinpoint areas requiring new or updated SOPs. Developed clear and user-friendly SOPs, incorporating flowcharts and visual aids to improve process clarity.
  • Generated new GTINs, updated them in our database, and submitted the GTINs to the GUDID database.
  • Developed and reviewed regulatory labeling for medical devices, ensuring compliance with FDA, EU, and international requirements, including accurate claims, instructions for use (IFU), and packaging.
  • Support international submissions with (Certificate of Foreign Government) CFGs, CFS, eCPPs, DoCs, LOAs, POAs, ISO certificates, Manufacturing statements, 510k statements and COAs. Worked on FURLs to order CFGs and eCPPs.
  • Created and managed STED documentation, ensuring adherence to IMDRF, ISO 13485, and regulatory standards.
  • Initiation of Country specific Declaration of Conformities (DOC)s and revisions and utilizing STED documentation to draft Declarations of Conformity by efficiently extracting and analyzing relevant data.
  • Updated technical files and design dossiers to meet the new EU MDR requirements.
  • Respond to requests from subsidiaries for certificates and declarations of conformities.
  • Managed the notarization, apostille authentication, and legalization of regulatory documents to ensure compliance with international medical device registration requirements.
  • Managed Export Certificates and facilitated product registration with USA regulatory agencies and international embassies. Successfully obtained approvals for global market access, particularly in EU, AFRICA, APAC, LATAM, and EMEA regions.
  • Supported the development and execution of global regulatory strategies, collaborating closely with international regulatory associates to register devices worldwide.
  • Maintained current knowledge of domestic and international medical device regulations, updating regulatory submission databases and distributing relevant information to appropriate personnel.

MedTech Peer Orientation Worker

St. Cloud State University
Minnesota
03.2019 - 08.2019
  • Orientation of new students to relevant university services and processes by creating an inclusive environment to welcome them to SCSU.
  • Assisting international students regarding university requirements. Providing awareness of course curriculum and other cultural programs involved in the University.

Quality Assurance & Quality Control Intern

Aurobindo Pharma Ltd
Telangana, India
03.2019 - 08.2019
  • Handled instrumentation such as TLC, HPLC, and GC.
  • Basic Review of quality documents MFR, BMR and process validation reports.
  • Conducted sterilization validation activities, including protocol development, execution, and data analysis, ensuring compliance with industry standards, accurately documented findings in line with regulatory requirements and quality management systems.
  • Revised and updated standard operating procedures (SOPs) as part of a process improvement project.
  • Verified peers work for accuracy and compliance, provided effective guidance to new analysts, and ensured a clean, safe, and organized laboratory environment.

Education

Master of Science - Regulatory Affairs and Services

St. Cloud State University
Minnesota
07.2023

Bachelor of Pharmacy -

Jawaharlal Nehru Technological University
Hyderabad, India
09.2020

Skills

  • 21 CFR Part 820, 21 CFR Part 807, and 21 CFR Part 11
  • ISO 13485, ISO 14971, and QSR
  • Quality Management System (QMS)
  • International regulations
  • Training and development
  • PLM systems, RegDesk, and SAP
  • 510(k) and PMAs
  • EU MDR
  • MS Office, SharePoint
  • STeD (Summary of Technical Documentation)
  • CAPA
  • Adobe Acrobat and DocuSign
  • GUDID and EUDAMED
  • Labeling
  • Project management
  • Analytical and critical thinking
  • Excellent communication
  • Technical documentation

Publications

Vamshi Gaikwod, et al. Evaluation of In Vitro Antiurolithiatic activity of Terminalia Chebula: International Journal of Pharmaceutical Research | Apr-June 2018 | Vol 10 | Issue  3.

Timeline

Quality Engineer

Zomedica Inc.
03.2025 - Current

Regulatory Affairs Specialist II

Solventum (3M)
09.2022 - 02.2025

MedTech Peer Orientation Worker

St. Cloud State University
03.2019 - 08.2019

Quality Assurance & Quality Control Intern

Aurobindo Pharma Ltd
03.2019 - 08.2019

Master of Science - Regulatory Affairs and Services

St. Cloud State University

Bachelor of Pharmacy -

Jawaharlal Nehru Technological University

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