Antika Sinha

About Antika Sinha

I am an alumna of University of Michigan with a Master\'s of Science in Biomedical Engineering. I am currently working as Regulatory Affairs Specialist at Medtronic. Previously i worked as a Regulatory Affairs Specialist I at Applied Medical and I was the Regulatory Support Specialist of Japan Market. I have 2 and half years of work experience as Quality Engineer at a biomedical imaging company Xoran Technologies LLC in Ann Arbor, Michigan. I am interested in Product development, Quality assurance and Regulatory strategies of a medical device. Experience with Root cause analysis, Corrective and Preventive action(CAPA) process,Quality Management System, 510k submission,DFMEA,Supplier Quality assessment activities(SRM),Internal audit process and SCAR(Supplier corrective action report). Knowledge of cGMP(current Good manufacturing practice), FDA design control, FDA 21 CFR §820, 21 CFR §803 and 21 CFR §806, 21 CFR Chapter I, Subchapter J( Part ),ISO 13485:2016 and ISO 14971 Medical Device Risk Management, verification and process validation (IQ, OQ and PQ), MDD(Medical device directive). Also, familiar with risk analysis, Health Hazard Analysis, UDI (Unique device identifier), MDR (Medical device reporting), ARO (Accidental radiation occurrence), defect report, FIA (Failure investigation analysis) and other quality metrics and tracking tools.

Experience

1. Senior Regulatory Affairs Specialist

   Medtronic

   Jul 2022 — Present · Plymouth, MN, US

Education

• University of Michigan - Rackham Graduate School

  Master of Science (MS), Bioengineering and Biomedical Engineering

  2016 — 2018

• Indian Institute of Technology, Kanpur

  Research Intern, Structural Biology Lab

  2014 — 2014

• Vellore Institute of Technology

  Bachelor of Technology (BTech), Biotechnology

  2010 — 2014