Aniket Khakhadiya
Regulatory Affairs | Quality Assurance
- Role
- Principal Regulatory Affairs Specialist at EBR Systems, Inc.
- Location
- San Jose, CA, US
- LinkedIn followers
- 500 followers
About Aniket Khakhadiya
10+ years in Regulatory Affairs and Quality Assurance in the medical device industry (Experience of working in a startup, small scale, mid-size and global company) • Experience with global medical device regulations and interfacing with Regulatory Agencies and Notified Bodies. Experience with audits - FDA, MDSAP, NB & International Regulatory Agencies.Passionate to contribute to the healthcare industry. Collaborating and learning from people with dynamic personalities and different backgrounds has added tremendous value and perspective to me, for which I am grateful and look forward to pass on in the years to come. In the words of legendary basketball coach John Wooden: “Never try to be better than someone else. Learn from others, and try to be the best you can be. Success is peace of mind which is a direct result of self-satisfaction in knowing you did your best to become the best you are capable of becoming.” Together Everyone Achieves More. Be the person who makes everyone feel like someone.Irrespective of industry, interested in collaborating and learning from people who are excited about personal development, have a growth mindset, and are driven to be a better version of themselves tomorrow.
Experience
Principal Regulatory Affairs Specialist
Jul 2024 — Present · Santa Clara, CA, US
Education
Vidyalankar Institute of Technology
Bachelor of Engineering (BE), Biomedical Engineering
2007 — 2011
University of Southern California
Master of Science (MS), Medical Devices and Diagnostic Engineering, Biomedical Engineering
2012 — 2013
Skills
- Biomechanics
- U.s. Food and Drug Administration (Fda)
- Regulatory Affairs
- Design Control
- Quality Assurance
- Validation
- Pma
- Microsoft Office
- Iso 14971
- 21 Cfr
- Corrective and Preventive Action (Capa)
- Matlab
- Medical Devices
- Capa
- Premarket Approval (Pma)
- Regulatory Requirements
- Quality System
- Biomedical Engineering
- Fda
- Iso 13485
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.