Headline

Regulatory Affairs Specialist | Expert in FDA & ISO Compliance | Medical Device Quality Management & Technical Writing | Complaint Handling Specialist

About

Results-driven Regulatory Affairs Specialist with 4.6 years of experience in the medical device industry, specializing in technical documentation, post-market surveillance, quality systems, and regulatory compliance for Class II/III products. Skilled in complaint handling, CAPA, DHF remediation, and regulatory dossier preparation aligned with ISO 13485, EU MDR, and 21 CFR 820. Experienced in supporting product registration activities, including compiling CE/FDA-compliant documentation, labeling reviews, and quality system assessments for global market access. While previous regulatory contributions were focused on U.S. and EU submissions, I have a solid understanding of emerging market pathways such as MOHAP (UAE) and SFDA (Saudi Arabia) and am well-prepared to support product registration efforts across the GCC region.

Location

India

AI stack

claude

gemini

openai

perplexity

Work experience

Senior Associate at Indegene, Dec 2025 - Present · 1 yr, Bengaluru, Karnataka, India

Lead Engineer at HCLTech, Nov 2024 - Jun 2025 · 8 mos, Chennai, Tamil Nadu, India, ❖ Managed the end-to-end complaint handling process for Class II medical devices such as infusion pumps, insulin delivery systems, and continuous glucose monitors (CGM). ❖ Assessed complaints for regulatory reportability in accordance with US FDA Medical Device Reporting (MDR) guidelines. ❖ Authored Medical Device Reports (MDRs) and detailed investigation summaries, supporting accurate and timely regulatory submissions. ❖ Conducted comprehensive investigations, including Root Cause Analysis and Risk Review Analysis. ❖ Formulate and monitor Corrective and Preventive Actions (CAPA) based on root cause findings. ❖ Collaborated with internal audit teams and regulatory bodies during inspections.

Technical Writer at Cyient, Sep 2023 - Nov 2024 · 1 yr 3 mos, Hyderabad, Telangana, India, ❖ Managed complaint investigations and regulatory reporting for Class II medical devices (e.g., Continuous Glucose Monitoring systems interlinked with insulin pumps, transmitters, and mobile applications for glucose level tracking and therapy) in accordance with US FDA 21 CFR Part 803/820 and EU MDR requirements. ❖ Prepared and supported regulatory documentation, including Medical Device Reports (MDRs), Periodic Safety Reports (PSURs), and Design History File (DHF) elements aligned with quality and compliance standards. ❖ Assisted in compiling submission documents such as 510(k) notifications, Premarket Approval (PMA) support files, ISO 13485 certificates, and CE marking documents for U.S. and EU regulatory submissions. ❖ Contributed to developing and reviewing technical documentation, including risk management files (per ISO 14971) and design input-output verification and validation (IOVV) artifacts. ❖ Collaborated with internal audit teams and supported external inspections by regulatory bodies, ensuring audit readiness and documentation accuracy. ❖ Gained exposure to international regulatory frameworks by participating in market-entry planning and simulated dossier preparation for registrations beyond core U.S./EU markets, enhancing readiness to support future product approvals in new geographies.

Member of Technical Staff at HCL Technologies, Jan 2021 - Sep 2023 · 2 yrs 9 mos, Chennai, Tamil Nadu, India, Project 1: Complaint Handling & Post-Market Surveillance (Jan 2021 -Feb 2022) Roles and Responsibilities: ❖ Handled complaints for Class III medical devices, including biopsy tools, angioplasty systems, stents, and filters. ❖ Evaluated reportability per FDA MDR guidelines and submitted MDRs with supplemental records. ❖ Performed root cause and risk analysis and documented CAPAs. ❖ Authored and submitted PSURs for Class II/III devices, ensuring alignment with global safety reporting requirements. ❖ Collaborated cross-functionally to consolidate safety data and meet submission timelines. Project 2: Design Control (Feb 2022 - Sep 2023) Roles and Responsibilities: ❖ Verified design test reports and validated medical device design documents (DHF Remediation) based on the Requirements and Traceability Matrix (RTM) to ensure design input-output verification and validation (IOVV). ❖ Ensured design control documentation met FDA 21 CFR Part 820.30 and ISO 13485 standards for regulatory compliance. ❖ Supported design reviews and cross-functional collaboration to ensure alignment of design inputs, outputs, and risk analysis. ❖ Managed design transfer documentation to manufacturing, ensuring traceability and compliance with internal quality standards. ❖ Conducted design verification and validation (V&V) activities, ensuring proper documentation and adherence to FDA and ISO requirements.

Education

Master of Business Administration - MBA, Health Services Management, College of Engineering, Guindy

Bachelor of Engineering - BE, Biomedical/Medical Engineering, Vel Tech Multi Tech Dr. Rangarajan Dr. Sakunthala Engineering College