Antika Sinha Email & Phone Number | I am an alumna of University of Michigan with a Master's of Science in Biomedical Engineering. I am currently working as Senior 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 1000-1050 ),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.

Antika Sinha

I am an alumna of University of Michigan with a Master's of Science in Biomedical Engineering. I am...
Saginaw, Michigan, United States

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Antika Sinha’s Email asinha@xorantech.com

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Antika Sinha’s Location Saginaw, Michigan, United States

Antika Sinha’s Current Industry Medtronic

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Work Experience

Medtronic

Senior Regulatory Affairs Specialist

2022-07-01 00:00:00 - Present

Applied Medical

Regulatory Affairs Specialist I

2019-09-01 00:00:00 - 2020-07-01 00:00:00

Xoran Technologies

Quality Engineer

2018-02-01 00:00:00 - 2019-09-01 00:00:00

Fireside Cafe

Student Coordinator

2017-09-01 00:00:00 - 2017-12-01 00:00:00

University Of Michigan

Pulse Patrol Design team

2016-09-01 00:00:00 - 2017-04-01 00:00:00

Indian Society Of Human Genetics

Associate/Student member

2015-09-01 00:00:00 - 2016-09-01 00:00:00

Accenture

Software Engineering Analyst

2014-08-01 00:00:00 - 2016-07-01 00:00:00

Allpa Medicinesltd

Pharma Intern

2014-06-01 00:00:00 - 2014-07-01 00:00:00

Coca Cola Bottling Plant

Intern

2013-06-01 00:00:00 - 2013-06-01 00:00:00

Vellore Institute Of Technology

Program Representative

2012-07-01 00:00:00 - 2013-05-01 00:00:00

Biotech Park Lucknow

Summer Internship

2012-06-01 00:00:00 - 2012-07-01 00:00:00

Skills

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Languages

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FAQ About Antika Sinha

Antika Sinha is located at
Saginaw, Michigan, United States

Antika Sinha is a I am an alumna of University of Michigan with a Master's of Science in Biomedical Engineering. I am currently working as Senior 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 1000-1050 ),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.

Antika Sinha currently works in the Medtronic |

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Antika Sinha has prior
experience in the following industries:
Applied Medical | Xoran Technologies | Fireside Cafe | University Of Michigan | Indian Society Of Human Genetics | Accenture | Allpa Medicinesltd | Coca Cola Bottling Plant | Vellore Institute Of Technology | Biotech Park Lucknow

Antika Sinha has the following professional experience:
Medtronic | Applied Medical | Xoran Technologies | Fireside Cafe | University Of Michigan | Indian Society Of Human Genetics | Accenture | Allpa Medicinesltd | Coca Cola Bottling Plant | Vellore Institute Of Technology | Biotech Park Lucknow