Yahavi Arumaikkannu

A regulatory and quality professional with over five years of hands-on experience assessing, investigating, and documenting active and non-active medical devices across EU MDR 2017/745 and ISO 13485-regulated environments. Direct experience with Class II active devices including ventilators (Philips Respiratory), infusion pumps, and catheters — spanning complaint failure investigation, IEC 60601-1 technical documentation, alarm and electrical malfunction analysis, and audit-ready regulatory submissions. Combines deep standards knowledge (IEC 60601-1, ISO 14971, EU MDR Articles 85–88) with a structured, analytical approach to assessment and process design.

Available immediately with full right to work in the UK — no sponsorship required.

Lead Associate — Customer Quality & Post-Market Surveillance - Genpact Ltd. (Cytiva — Global Life Sciences Client) - India, supporting UK/EU operations

(2024-03 - 2024-12)

• Managed end-to-end complaint investigation for ~120+ complaints per quarter across filtration, sterility, and microbiological process devices; maintained 100% audit-trail compliance in Veeva Vault QMS.
• Led PMS trending analysis and authored trend reports directly informing 3 CAPA initiations under EU MDR 2017/745 within 6 months; zero major non-conformances during audit cycles.
• Reported adverse events and technical complaints within required regulatory timeframes; coordinated cross-functional resolution with QC, Microbiology, Validation, and Manufacturing teams.

Complaints Handling Specialist — Active Medical Device Vigilance - iDexcel Technologies Ltd. - India — Client: Philips Respiratory (UK/EU)

(2023-02 - 2023-09)

• Led complaint failure investigations for Philips Respiratory ventilators (Class II active medical devices) — specialising in alarm failures, software/electrical malfunctions, and patient safety incidents; applied structured RCA methodology (8D, 5 Why, Fishbone) to identify root causes with full technical traceability.
• Investigated electrical and software malfunction complaints across active device portfolios, documenting failure modes, contributory factors, and corrective actions in a manner directly aligned with IEC 60601-1 safety and performance requirements.
• Prepared and supported regulatory submissions to Notified Bodies and the FDA relating to active device complaints; supported audit responses and maintained audit-ready complaint files for Competent Authority review under EU MDR 2017/745.
• Authored PMSR/PSUR content contributions and FSCA documentation under EU MDR Articles 85–86; maintained all records to Notified Body review standard — covering one of the world's most regulated categories of active medical device.
• Processed 80+ complaints per month across active and non-active device portfolios; produced quality trend reports identifying systemic failure modes, contributing to CAPA actions that reduced repeat complaint rates by approximately 20%.

Medical Writer — Regulatory & Quality Operations (Active Devices) - HCL Technologies Ltd. - India — Global Medical Device Clients

(2020-03 - 2023-01)

• Authored and reviewed technical documentation and SOPs for infusion pumps and catheters against IEC 60601-1 general safety and essential performance requirements — producing assessment-ready documentation used in regulatory submissions and Notified Body reviews.
• Developed and maintained 200+ SOPs, work instructions, quality records, and technical files to ISO 13485 and FDA 21 CFR Part 820 standards across active and non-active device programmes; templates adopted across 4 project teams, reducing QA review cycle time by ~30%.
• Prepared and reviewed technical documentation packages for Notified Body and FDA submissions; supported two successful FDA inspection cycles without major findings — demonstrating the rigorous standards alignment required for active device regulatory assessment.
• Supported CAPA documentation, non-conformance reporting, and change control for active device programmes; maintained version-controlled audit-ready records throughout.
• Established and enforced version control processes across all QMS documentation relating to IEC 60601-1-governed devices, ensuring records remained current for regulatory inspection readiness.

Downstream Analyst - Swim Biopharma Pvt. Ltd. - India

(2019-04 - 2020-03)

• Performed downstream analytical testing and maintained GMP-compliant batch records, deviation reports, and failure investigation logs to pharmaceutical quality standards.

MSc - Pharmaceutical Science - University of Greenwich, London, UK (2025-01 - 2026-02)

MBA - Technology Management - Alagappa University, India (2022-01 - 2023-12)

B.Tech - Biotechnology - Anna University, India (2015-08 - 2019-03)