Arunika Koley

Regulatory professional with M.Tech in Biotechnology and direct experience in medical device vigilance from my internship as MDR Vigilance Specialist on Medtronic's Powered Surgical Solutions Quality & Regulatory team at MEIC facility, Hyderabad. During this time, I handled 1600+ complaints with EU MDR Article 87 vigilance reporting and EUDAMED MIR submissions, US FDA 21 CFR Part 803 MDR reporting, IMDRF coding and CAPA/remediation regulatory submissions. I process complaints end-to end in Global Complaint Handling platform- reportability decisions, investigation summary, product analysis, IMDRF coding, event descriptions while coordinating Good Faith Effort (GFE) communications across global facilities to close information.

In parallel, I track products and service reports in SAP CRM based on the complaints I handle, linking analysis product analysis data and services details to build out complete complaint handling documentation. My background also includes a research foundation in molecular biology, cancer immunology and epigenetics, with a published review paper and a conference presentation to show for it. I'm looking to bring this combination into a regulatory affairs role, with an eye toward growing into pre-market submissions and global registrations.

MDR Vigilance Specialist (Intern) - Medtronic- Powered Surgical Solutions, Quality & Regulatory MEIC Facility - Hyderabad

• Prepared and submitted Medical Incidents Reports (MIRs) via EUDAMED under EU MDR Article 87, along with complaint/MDR reports under US FDA 21 CFR Part 803 within their regulatory timelines.
• Made reportability decisions for the US, EU, Non-EU, Canada and Australia on case- specific regulatory and working instructions.
• Conducted product analysis, investigation summaries, and event description for complaint cases across global regions, forming the basis for reportability and regulatory submissions.
• Handled 1600+( approx.) complaints along with supported in investigation summaries, CAPA tracking and remediation regulatory report submission with the Quality & Regulatory Affairs team across devices including the MIDAS REX (MR8 and MR7)
• Assigned IMDRF codes to classify adverse events, patient impact and complaint data, and coordinated Good Faith Effort (GFE) communication across global facilities to close the pending returns and pending clarifications.
• Kept case data consistent across SAP CRM and GCH- from complaint intake end-to-end processing through regulatory classification to final reporting.
• Tracked evolving EU MDR and US FDA requirements to keep vigilance practices current, managing several concurrent cases against strict regulatory timelines.

M.Tech - Biotechnology - SRM Institute of Science and Technology

B.Tech - Biotechnology - Heritage Institute of Technology