Yagna ANGIRISH
Irvine,CA
Summary
Skilled at preparing and submitting regulatory documentation, including reviewing materials, technical data and accuracy of filings. Articulate and personable with exceptional data analysis, report writing and recordkeeping abilities. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
8
8
years of professional experience
Work History
Sr. Regulatory Affairs Specialist
Edwards Lifesciences
11.2018 - Current
- Developed regulatory strategies and streamlined submissions for vascular surgery products by developing efficient processes and documentation templates.
- Authored US FDA Class II 510(k)s, LTFs, and EU MDD and MDR Class III, Class IIa Change Notifications, and TF/TD updates for various medical devices.
- Established strong rapport with cross-functional teams to integrate regulatory considerations and to develop risk mitigation strategies
- Created guides for best practices on eSTAR submissions and Regulatory Affairs (RA) plans
- Championed a culture of continuous improvement within the regulatory department.
- Mentored interns and CRDPs, fostering professional growth and enhancing team performance.
- Prioritized project-related tasks to efficiently complete essential tasks( i.e. ECRs, NoCs, SARs, ePAC).
- Optimized labeling content for ensuring accuracy, clarity, and compliance
- Provided input on promotional claims based on relevant regulations.
Regulatory Affairs Specialist
Smith & Nephew, Inc
07.2017 - 11.2018
- Prepared submissions for International Market (IRAMEA, LATAM, EU, etc.) agencies to obtain or maintain regulatory approvals with supporting documents including IFU, packaging and design validations, labels, etc.
- Developed regulatory strategy for new or modified orthopedic products (US Class I, II, & III)
- Supported product development by offering guidance on applicable regulations new product development team for Class II device
- Led and managed the preparation of a EU renewal design dossier for Class III hip orthopedic implants with a cross-functional team
- Managed change assessments and impact on domestic and international market registration
- Prepared and maintained core document inventory
- Shadowed 510(k) and CE marking process
Regulatory Compliance Specialist
Smith & Nephew, Inc
12.2015 - 07.2017
- Processed product complaints and submitted adverse event reports for Orthopedic devices, adhering to regulatory guidelines.
- Analyzed complaint-related data and responded to Regulatory and Internal inquiries.
- Collaborated in cross-functional teams to track and trend product failures and initiate corrective actions.
- Maintained relations with field sales reps to ensure timely product compliance reporting.
- Developed procedural documents for complaint processes and led CAPAs to improve workflow.
- Participated as Subject-Matter-Expert in audits and responded to cited issues
Education
Bachelor of Science - Biomedical Engineering
Georgia Institute of Technology
Atlanta, GA05.2015
Skills
- Product Lifecycle Management
- Requests for information
- Medical Device Regulations
- Post-Market Surveillance
- Continuous Improvement
- Interpersonal Effective Communication
- ISO Standards
- Problem-solving abilities
Professional Development Affiliations
- Regulatory Affairs Collaboration Committee - Critical Care Liaison
- E.NOW Leadership - Networking Committee Chair (2020-2022)
- Toastmasters Officer (2019-2022)
Timeline
Sr. Regulatory Affairs Specialist
Edwards Lifesciences
11.2018 - Current
Regulatory Affairs Specialist
Smith & Nephew, Inc
07.2017 - 11.2018
Regulatory Compliance Specialist
Smith & Nephew, Inc
12.2015 - 07.2017
Bachelor of Science - Biomedical Engineering
Georgia Institute of Technology
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