Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Aishwarya Kalyankar

Santa Clara,CA

Summary

Highly skilled Regulatory Affairs Specialist with over 5 years of experience in medical device regulatory frameworks, Molecular Diagnostics, focusing on post-market surveillance, regulatory submissions (FDA 510(k), MDR), and ensuring compliance with FDA and ISO 13485 standards. Proven expertise in driving cross-functional collaboration, supporting product development, and managing regulatory compliance across the product lifecycle. Demonstrated ability to lead regulatory strategy, manage post-market actions, and maintain QMS procedures. Adept at preparing and reviewing regulatory submissions, complaint handling, and regulatory intelligence, with a strong emphasis on continuous quality improvement and risk management.

Overview

5
5
years of professional experience
1
1
Certification

Work History

Regulatory Post Market Surveillance Analyst

Intuitive Surgical Inc.
06.2023 - Current
  • Managed and investigated daily customer complaints to ensure timely and thorough resolution, achieving backlog reduction goals (125-150 complaints per week).
  • Conducted root cause analysis and failure mode investigations, escalating adverse events.
  • Created and submitted MDR (Medical Device Reports) to the FDA for all reportable complaints, maintaining strict adherence to regulatory requirements and ensuring timely submissions.
  • Evaluated and ensured complaint files meet regulatory and company standards, collaborating with Regulatory Authorities and Post Market Investigation (PMI) groups.
  • Developed and improved complaint handling processes, contributing to cross-functional process enhancement initiatives.
  • Liaised with hospitals and service providers to retrieve RMAs and customer feedback for thorough complaint resolution.
  • Led the preparation and submission of 510(k) applications, ensuring compliance with FDA requirements and guidelines.
  • Developed comprehensive documentation, including technical files and design history documents, for successful 510(k) submissions.
  • Organized and participated in pre-submission meetings with FDA representatives to clarify submission requirements and address regulatory questions.
  • Managed post-market surveillance activities related to 510(k) products, ensuring ongoing compliance and addressing any regulatory issues.
  • Provided peer review and mentor new hires in regulatory compliance best practices.


Research and Quality Control Scientist

Anchor Molecular Inc.
06.2022 - 05.2023
  • Led research and quality control for molecular diagnostic products, ensuring compliance with FDA and ISO 13485 standards.
  • Spearheaded the development and validation of IVD products using NGS, qPCR, and ddPCR, contributing to 510(k) submission for FDA clearance.
  • Developed comprehensive documentation, including technical files and design history documents, for successful 510(k) submissions.
  • Collaborated with cross-functional teams to create regulatory strategies tailored to specific products, facilitating the efficient submission of 510(k) applications.
  • Conducted thorough analysis of clinical and non-clinical data to support the safety and effectiveness claims in 510(k) submissions.
  • Monitored the status of 510(k) submissions and coordinated responses to FDA requests for additional information, ensuring timely completion and approval and implemented risk management strategies in alignment with 510(k) requirements, enhancing product safety and compliance.
  • Implemented rigorous quality control protocols, reducing product defects and improving assay performance through SPC methods.
  • Facilitated cross-functional collaboration to optimize product design, transferring seamless production from R&D to manufacturing.
  • Developed comprehensive reports for internal and external stakeholders, summarizing validation outcomes and quality performance metrics.

Clinical Research Associate (CRA)

Ascentrik Research
12.2019 - 01.2021
  • Managed clinical trial phases for various drug studies, ensuring compliance with GCP and SOP standards.
  • Coordinated virtual meetings with investigators and site staff to ensure smooth trial execution, resulting in timely Phase I/II study completion.
  • Conducted source data verification and maintained regulatory-compliant electronic study files.

Education

Master of Science (M.S.) - Biomedical Engineering

SUNY Buffalo
Buffalo, NY
05.2022

Master of Science (M.S.) - Biotechnology

Ramnarain Ruia College
05.2019

Bachelor of Science (B.S.) - Biotechnology

Kirti M. Doongursee College
05.2017

Skills

  • Regulatory Compliance: FDA 21 CFR Part 820, Part 11, ISO 13485, 14971, MDR Submissions, EU MIR, FDA 510(k), EUA applications
  • Post-Market Surveillance: Complaint Processing, Risk Assessment, Root Cause Analysis, CAPA
  • Quality: Quality Management System (QMS) / eQMS, Document Control
  • Tools & Software: TrackWise, Agile, SAP CRM, MATLAB, SOLIDWORKS, Artemis, Snowflake, Endnote, OneNote, Microsoft Office
  • Data Analysis & Reporting: Failure Mode & Effects Analysis (FMEA), DHR Review, SPC Methods
  • Quality Control: Non-Conformance (NCMRs), Product Validation, Process Audits

Certification

  • Lean Six Sigma Foundations
  • Clinical Research Associate (CRA) Certification

Timeline

Regulatory Post Market Surveillance Analyst

Intuitive Surgical Inc.
06.2023 - Current

Research and Quality Control Scientist

Anchor Molecular Inc.
06.2022 - 05.2023

Clinical Research Associate (CRA)

Ascentrik Research
12.2019 - 01.2021

Master of Science (M.S.) - Biotechnology

Ramnarain Ruia College

Bachelor of Science (B.S.) - Biotechnology

Kirti M. Doongursee College

Master of Science (M.S.) - Biomedical Engineering

SUNY Buffalo

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Aishwarya Kalyankar