BHARGAVI KANNAN
USA
Summary
Regulatory Affairs and Quality professional with 5+ years of experience in FDA-regulated medical devices, specializing in Software as a Medical Device (SaMD), design controls, and 510(k) submissions. Proven track record in regulatory strategy, software change assessments, and cross-functional collaboration to support product lifecycle compliance and global market access.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Quality Engineer II
Ischema View
Colorado
01.2020 - Current
- Strengthened best-practice quality assurance (QA) and testing strategies for software development life cycle (SDLC) products, ensuring regulatory and FDA 510(k) conformance to enhance quality and customer satisfaction for over 20 medical device projects annually
- Direct quality assurance, regulatory, and engagement management life cycle processes for Class II medical device product development per the FDA design controls
- Performed regulatory impact assessments for software and design changes, determining submission requirements and compliance pathways.Contributed to regulatory strategy for SaMD features across product lifecycle.
- Championed continuous process improvement by liaising with design engineering, engineering, marketing, and regulatory project teams to enhance KPI productivity metrics
- Evaluated internal audit data in partnership with regulatory, analyzed pre and post-market surveillance data, and fostered strong collaboration among QA, regulatory, and FDA teams, achieving 100% compliance with CAPA and FMEA requirements
Project Associate
USC Regulatory Science Projects
Los Angeles, California
01.2019 - 05.2020
- Directed CAPA and FMEA efforts to improve solutions management and support continuous process improvement initiatives.
- Expedited project management support for several regulatory science project tasks
- Completed traditional 510(k) application for GE device
- Identified several standard operating procedure (SOPs) templates for medical device manufacturing use
Regulatory Affairs and QA Intern
Micro Medical Devices
Calabasas, California
01.2019 - 03.2020
- Developed comprehensive 510(k) device master record, ensuring adherence to FDA requirements and facilitating regulatory approval process.
- Managed regulatory and quality initiatives for portable hand-held ophthalmology device company, ensuring successful product marketing in US & EU.
- Collaborated with QA management to enhance ISO compliance, supporting maintenance of quality assurance standards.
- Led CAPA analysis to identify and address nonconformances, enhancing product safety and reliability.
Graduate Research Assistant
USC Stevens Neuroimaging & Informatics Institute
Los Angeles, California
01.2018 - 01.2019
- Coordinated clinical project management for university neuroimaging and informatics research center, supporting effective research execution
- Supported clinical trial of transcranial direct current stimulation (tDCS) application and MRI analysis adopting good clinical and laboratory practices (GCP/CLP), which ensured successful Institutional Review Board (IRB) submission
- Developed and implemented project management strategies for research coordinators and postdoctoral teams, enhancing collaboration and workflow
Education
Master of Science - Biomedical Engineering
University of Southern California
Los Angeles05-2020
Bachelor of Engineering - Biomedical Engineering
Anna University
Chennai, India05-2018
Skills
- FDA-QSR and GCP compliance
- FDA 510(k) submission
- EU-MDD and MDR regulations
- ISO 13485 auditing
- ISO 14971 risk management
- Medical device design control
- FMEA and root cause analysis
- Quality assurance methodologies
- QMS implementation and oversight
- Complaint management
- Nonconformance resolution
- Post-market surveillance practices
- Statistical process control
- SAMD product management strategies
- LabVIEW and MATLAB proficiency
- Project management with MS Project
- Microsoft Office suite expertise
Certification
- ISO 14971:2019 risk management for medical devices
- Six Sigma green belt
- Periodic Safety Update Reports & MDR Vigilance
- SDLC for SaMD certification
- HIPPA Training Program
Timeline
Quality Engineer II
Ischema View
01.2020 - Current
Project Associate
USC Regulatory Science Projects
01.2019 - 05.2020
Regulatory Affairs and QA Intern
Micro Medical Devices
01.2019 - 03.2020
Graduate Research Assistant
USC Stevens Neuroimaging & Informatics Institute
01.2018 - 01.2019
Master of Science - Biomedical Engineering
University of Southern California
Bachelor of Engineering - Biomedical Engineering
Anna University