Chiranjit Deka Email & Phone Number | QA/RA Specialist with over 20 years of experience in the medical device industry spanning all aspects of product life cycle, from innovation, design, and manufacturing to regulatory compliance. Quality/Regulatory Compliance Experience: ISO 13485:2016, MDSAP and IVDD/MDD Lead Auditor UKCA Auditor IVDD Technical File Reviewer/Product Assessor MDSAP Program Manager Proficient in medical device regulations of the FDA, Health Canada, Japan PMDA/MHLW, Australia TGA, Brazil ANVISA and European IVDD, IVDR, MDD, and MDR. Product Development Expertise: IVD assays, reagents and instrumentation. Complex electromechanical devices (Hematology, Immunoassay, Molecular Diagnostics) for POC and Reference Lab Applications. Rapid Tests (lateral flow devices) for professional and at-home use. Six-Sigma, NPD Process.

Chiranjit Deka

QA/RA Specialist with over 20 years of experience in the medical device industry spanning all aspect...
Durham, North Carolina, United States

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Chiranjit Deka’s Email chiranjit.deka@ul.com

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Chiranjit Deka’s Location Durham, North Carolina, United States

Chiranjit Deka’s Current Industry Ul Solutions

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MDSAP Program Manager, Regional Lead Reviewer, and Certificate Decision Maker

2018-01-01 00:00:00 - Present

CTO and CEO

2013-01-01 00:00:00 - 2018-01-01 00:00:00

Vice President of Product Development

2010-01-01 00:00:00 - 2013-01-01 00:00:00

R&D Manager II

2005-01-01 00:00:00 - 2010-01-01 00:00:00

Senior Director of Engineering

2001-01-01 00:00:00 - 2004-01-01 00:00:00

Sr. Staff Systems Engineer

1996-01-01 00:00:00 - 2001-01-01 00:00:00

Member of Technical Staff

1993-01-01 00:00:00 - 1996-01-01 00:00:00

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Chiranjit Deka is a QA/RA Specialist with over 20 years of experience in the medical device industry spanning all aspects of product life cycle, from innovation, design, and manufacturing to regulatory compliance. Quality/Regulatory Compliance Experience: ISO 13485:2016, MDSAP and IVDD/MDD Lead Auditor UKCA Auditor IVDD Technical File Reviewer/Product Assessor MDSAP Program Manager Proficient in medical device regulations of the FDA, Health Canada, Japan PMDA/MHLW, Australia TGA, Brazil ANVISA and European IVDD, IVDR, MDD, and MDR. Product Development Expertise: IVD assays, reagents and instrumentation. Complex electromechanical devices (Hematology, Immunoassay, Molecular Diagnostics) for POC and Reference Lab Applications. Rapid Tests (lateral flow devices) for professional and at-home use. Six-Sigma, NPD Process.

Chiranjit Deka has prior
experience in the following industries:
Indexus Biomedical | Advanced Liquid Logic | Idexx Laboratories | Beckman Coulter Life Sciences | Beckman Coulter Diagnostics | Los Alamos National Laboratory

Chiranjit Deka has the following professional experience:
Ul Solutions | Indexus Biomedical | Advanced Liquid Logic | Idexx Laboratories | Beckman Coulter Life Sciences | Beckman Coulter Diagnostics | Los Alamos National Laboratory