Chiranjit Deka chiranjit.deka@ul.com & | 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 aspects of product...

Durham, North Carolina, United States

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Chiranjit Deka’s Emails [email protected]

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

Chiranjit Deka’s Expertise 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’s Current Industry Ul Solutions

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Work Experience

Ul Solutions

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

Mon Jan 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Present

Indexus Biomedical

CTO and CEO

Tue Jan 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)

Advanced Liquid Logic

Vice President of Product Development

Fri Jan 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jan 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time)

Idexx Laboratories

R&D Manager II

Sat Jan 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jan 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time)

Beckman Coulter Life Sciences

Senior Director of Engineering

Mon Jan 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jan 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time)

Beckman Coulter Diagnostics

Sr. Staff Systems Engineer

Mon Jan 01 1996 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time)

Los Alamos National Laboratory

Member of Technical Staff

Fri Jan 01 1993 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 1996 00:00:00 GMT+0000 (Coordinated Universal Time)

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FAQ About Chiranjit Deka

Chiranjit Deka is located at
Durham, North Carolina, United States

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. Ul Solutions

Chiranjit Deka currently works in the
Ul Solutions

Chiranjit Deka specializes in
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 speaks the following languages:
No languages available.

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 .