Anagha Karnik

About Anagha Karnik

Strategic and influential leader with proven track record building strong regulatory affairs teams and driving results for Class II and Class medical devices. 15+ years of product development and sustaining experience covering cardiovascular, endovascular, IVD medical devices and polymers. Skill set includes EFS IDEs, pivotal IDEs, Modular PMAs, 510(k)s, CE Mark - MDD Design Dossiers, Technical Files, MDR Technical Documentation (TD), International Dossiers, Clinical Evaluation Reports (CERs). Extensive experience in regulatory authority(ies) interactions/meetings, cross functional New Product Development (NPD) and sustaining (operations/manufacturing) team support, regional team(s) support, leading and managing domestic and international audits, CAPAs, complaints, MDRs, recall reports/field safety corrective actions, technical standards assessments, Ad/Promo material(s) review. Currently, a proud member of the Edwards TMTT Regulatory Affairs team. At Edwards, it’s about more than just a career in Regulatory Affairs—it’s about having real impact and making a difference in patients’ lives across the globe. If you are interested in learning more about current and future opportunities with us, please connect with Megan Mielcarek from our Regulatory Affairs Talent Acquisition team on LinkedIn.

Experience

1. Senior Director Regulatory Affairs

   Edwards Lifesciences

   Mar 2023 — Present

Education

• University of Southern California

  MS, Biomedical/Medical Engineering

• University of Mumbai

  B.S., Biomedical Engineering

  2001 — 2005

Skills

• Regulatory Requirements
• Regulatory Affairs
• Clinical Trials
• Software Documentation
• Biocompatibility
• Class Iii Medical Devices
• Quality System
• V&V
• 5s
• U.s. Food and Drug Administration (Fda)
• Technical Files
• Cgmp Practices
• Lean Tools
• Product Development
• Validation
• Six Sigma
• Gmp
• Management
• Iso 13485
• Medical Devices
• Capa
• Audits
• Design Control
• Cross-Functional Team Leadership
• Iso 14971
• Regulatory Submissions
• Biotechnology
• Ce Marking
• Sop
• Fda
• 21 Cfr
• Biomedical Engineering
• Pma