Summary
Overview
Work History
Education
Skills
Certification
Awards
LEADERSHIP
TOOLS
Timeline
Prabhu Muthu

Prabhu Muthu

Bangalore

Summary

Senior Technical Lead with over 12 years as Quality and Regulatory Affairs specialist experience in the medical device industry, specializing in global regulatory strategy, product approvals (510(k), CE Marking, PMA), and compliance with FDA, EU MDR, and other international regulations. Proven expertise in leading regulatory submissions, supporting audit and Product lifecycle management support. Cross-functional collaboration, mentoring teams, and driving efficient global market access through strategic regulatory planning.

Regulatory affairs professional with comprehensive expertise in navigating complex regulatory landscapes and ensuring compliance. Proven ability to drive successful submissions and approvals for critical projects while fostering collaborative team environments and adapting to evolving regulatory requirements. Reliable in delivering results and maintaining high standards.

Overview

13
13
years of professional experience
5
5
Certifications

Work History

Senior Regulatory Affairs Specialist

Stryker Global Technology Centre
08.2024 - Current
  • Spearheaded successful EU regulatory submissions for spine products by preparing and compiling technical documentation, General Safety and Performance Requirements (GSPR) checklists, Declarations of Conformity (DoC), and Instructions for Use (IFUs).
  • Updated and maintained regulatory templates and internal procedures to comply with changing global and EU requirements; supported global regulatory submissions across multiple markets.
  • Provided regulatory support for the EEMEA region, including assistance with renewals, new submissions, deficiency responses, and handling customer inquiries or ad-hoc requests.
  • Supported change management processes by initiating and routing Management of Change (MoC) and impact assessments, as well as tracking and securing required approvals.
  • Reviewed Clinical Evaluation Reports (CER) and Clinical Evaluation Plans (CEP) to ensure alignment with regulatory standards and collaborated with cross-functional teams for comprehensive compliance.

Senior Lead – RA

HCL Technologies Ltd
02.2019 - 08.2024
  • Led preparation of Summary Technical Documentation (STED) for both EU MDR 2017/745 and US FDA submissions for orthopedic implants, instruments, and ablation catheter product lines.
  • Orchestrated technical file remediation initiatives aligned with EU MDR 2017/745, including generation of GSPR (Annex I) checklists, Annex II technical documentation, lists of applicable standards, and Instructions for Use (IFU) for orthopedic and ablation devices.
  • Owned BUDI (Basic UDI-DI) device grouping activities, prepared Appendix I rationale forms and Appendix IV request forms for all associated technical documentation.
  • Generated and managed Engineering Change Requests (ECRs) and Change Notices using Product Lifecycle Management (PLM) systems—Agile, Windchill, and SAP—for stakeholder approval and document release.
  • Conducted comprehensive reviews of clinical documentation—including Clinical Evaluation Plans, CER, and SSCP to ensure EU MDR compliance, as well as Post-Market Surveillance plans and reports.
  • Managed a team of quality and regulatory professionals, providing guidance on design controls, new product development (NPD), and regulatory pathways.

Technical Lead

Tata Consultancy Services Ltd
02.2013 - 01.2019
  • Supported registration and submission processes for Class II orthopedic implant devices (Knee and Hip Joints) in accordance with US FDA and EU regulatory requirements.
  • Reviewed key design control documents, Device Master Records (DMRs), and Risk Management Files to ensure regulatory and quality compliance.
  • Reviewed Design History File (DHF) documents—such as User Needs, Design Inputs/Outputs, Verifications, and Validations—prepared by team members.
  • Demonstrated expertise in New Product Development (NPD) methodologies, design controls, and product compliance per ISO 13485 and ISO 14971.
  • Reviewed 2D engineering drawings for Class I and II orthopedic implants, surgical instruments, and post-surgical products.
  • Executed business transition operations for R&D projects, delivering end-to-end product support and ensuring adherence to 21 CFR Part 820 Quality System Regulation.

Education

Bachelor Of Engineering - Mechanical Engineering

Institute of Road And Transport Technology
01.2012
  • Anna University, Erode
  • GPA: 8.3 CGPA

Skills

EU MDR 2017/745

Certification

Regulatory Compliance Certificate (RCC-MDR) – From RAPS

Awards

Achievers League “O – Infinity Award “For Three Consecutive Years From Hcl Leadership Team, Knowledge Champion For Ond Quarter 2023, Customer Reward and Appreciation for Successful Completion of BUDI Project from Depuy Synthes

LEADERSHIP

Led a high Performing Team of Six through the End-to-End EU MDR Implementation Process for Orthopedic products, showcasing regulatory expertise and delivering full compliance within the targeted 15-month timeframe.

TOOLS

  • Agile PLM, Azure Devops, MasterControl, Windchill, SAP
  • QuickBase, PLCM Tracker
  • Microsoft Office365
  • AutoCAD 2016

Timeline

Senior Regulatory Affairs Specialist - Stryker Global Technology Centre
08.2024 - Current
Senior Lead – RA - HCL Technologies Ltd
02.2019 - 08.2024
Technical Lead - Tata Consultancy Services Ltd
02.2013 - 01.2019
Institute of Road And Transport Technology - Bachelor Of Engineering, Mechanical Engineering

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Prabhu Muthu