Gopal Mohanty Email & Phone Number | Transformational QA and RA Executive with extensive global leadership experience driving efficiency and improvement in New Product Development and Launch, Quality Systems and Compliance, Regulatory Affairs, Product Submissions and Approvals, Operations Quality, Supplier Quality Management and Pre/Post Market Product Quality. Solid proficiency in managing regulatory agency communication, organizational design and talent development, project management, training, coaching, mentoring, and obtaining measurable business results. Key Accomplishments •Improved the compliance rating across 4 sites in 2 years from red to green. Drove significant improvement in product quality across 4 product platforms. Reduced complaints, MDRs, and Field Actions. •Deployed quality management system meeting global regulatory requirements (ISO 13485:2016, ISO- 14971, MDD, MDR, IVDR, 21 CFR part 820, 814, 812, 50, 56, 11, CMDCAS, ISO 62304, SaMD). •Implemented Medical Device Single Audit Program (MDSAP) and initiated deployment of EUMDR. •Led multiple critical CAPAs resulting in cumulative savings of 3.9MM and addressing regulatory issues. •Championed several six sigma (DMAIC) projects improving complaint resolution timing by 40%. * Created Design Assurance & Reliability Engineering Organizations. Implemented enterprise-wide quality management systems including risk management (ISO 14971), Design Control (Part 820.30), software life cycle process (ISO 62304), and SaMD involving hardware, software/firmware, and consumables. •Received 510K clearances from CDRH, CBER, and CDER involving instruments, software, & consumables. •Received 4 EU MDR compliant CE Marks protecting 25MM revenue. Drove regulatory strategy globally appropriately scaling to product classification and managed MDR transition plan. Core Competencies •Medical Device, Pharmaceutical, Combination Products, Lab Management •Audits, Investigations, Warning 483s, Consent Decree Remediation •Organizational Design, Mentoring & Coaching, Talent Development •Design Control, Risk Management, Design Transfer, Operations Quality, Post Market, Suppler Quality •Regulatory Strategy, Regulatory Submission, Clinical Evaluation, Sterilization, Biocompatibility, •Acquisition & Integration, Long/Short Term Strategy, Budgeting, Customer Management Industry Specific Expertise •cGMP, ISO 13485, 14971, MDSAP, MDD, MDR, IVDR, CFR Part 211, 210, 820, 814, 812, 56, 50, 4, 3 •510K, De Novo, PMA, Labeling, CE Marketing •Design Control, Validation, RI, SPC, KAIZEN, CAPA, NCRs, TDs, DfSS, DMAIC, DfR, GLP, GCP

Gopal Mohanty

Transformational QA and RA Executive with extensive global leadership experience driving efficiency...
United States

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Gopal Mohanty’s Email gopal.mohanty@integer.net

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Gopal Mohanty’s Location United States

Gopal Mohanty’s Current Industry Nervonik Clarix Imaging California State University Los Angeles

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Work Experience

Nervonik

Advisory Board Member

2024-05-01 00:00:00 - Present

Clarix Imaging

Vice President Of Regulatory Affairs, Quality Assurance, And Compliance

2023-03-01 00:00:00 - Present

California State University Los Angeles

Adjunct Professor And Advisor, Industrial Management Graduate Program

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

Integer Holdings

Vp, Quality And Regulatory Affairs

2021-05-01 00:00:00 - 2022-10-01 00:00:00

Advanced Energy

Global Director Of Reliability And Quality Engineering

2018-05-01 00:00:00 - 2021-05-01 00:00:00

Danaher

Director Of Quality, Compliance, And Regulatory Affairs

2014-01-01 00:00:00 - 2018-01-01 00:00:00

Johnson And Johnson

Worldwide Director Of Operations Quality

2013-02-01 00:00:00 - 2014-01-01 00:00:00

Life Technologies

Director Of Global Quality Systems, Compliance, And Supplier Quality

2011-01-01 00:00:00 - 2012-12-01 00:00:00

Boston Scientific

Director Of Design Assurance And Systems Validation

2009-03-01 00:00:00 - 2010-12-01 00:00:00

Baxter Healthcare

Director Of Quality And Reliability Engineering

2004-06-01 00:00:00 - 2009-03-01 00:00:00

Ford Motor

Manager Of Reliability Engineering, North American Car Line Division

1999-09-01 00:00:00 - 2001-11-01 00:00:00

Skills

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Languages

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FAQ About Gopal Mohanty

Gopal Mohanty is located at
United States

Gopal Mohanty is a Transformational QA and RA Executive with extensive global leadership experience driving efficiency and improvement in New Product Development and Launch, Quality Systems and Compliance, Regulatory Affairs, Product Submissions and Approvals, Operations Quality, Supplier Quality Management and Pre/Post Market Product Quality. Solid proficiency in managing regulatory agency communication, organizational design and talent development, project management, training, coaching, mentoring, and obtaining measurable business results. Key Accomplishments •Improved the compliance rating across 4 sites in 2 years from red to green. Drove significant improvement in product quality across 4 product platforms. Reduced complaints, MDRs, and Field Actions. •Deployed quality management system meeting global regulatory requirements (ISO 13485:2016, ISO- 14971, MDD, MDR, IVDR, 21 CFR part 820, 814, 812, 50, 56, 11, CMDCAS, ISO 62304, SaMD). •Implemented Medical Device Single Audit Program (MDSAP) and initiated deployment of EUMDR. •Led multiple critical CAPAs resulting in cumulative savings of 3.9MM and addressing regulatory issues. •Championed several six sigma (DMAIC) projects improving complaint resolution timing by 40%. * Created Design Assurance & Reliability Engineering Organizations. Implemented enterprise-wide quality management systems including risk management (ISO 14971), Design Control (Part 820.30), software life cycle process (ISO 62304), and SaMD involving hardware, software/firmware, and consumables. •Received 510K clearances from CDRH, CBER, and CDER involving instruments, software, & consumables. •Received 4 EU MDR compliant CE Marks protecting 25MM revenue. Drove regulatory strategy globally appropriately scaling to product classification and managed MDR transition plan. Core Competencies •Medical Device, Pharmaceutical, Combination Products, Lab Management •Audits, Investigations, Warning 483s, Consent Decree Remediation •Organizational Design, Mentoring & Coaching, Talent Development •Design Control, Risk Management, Design Transfer, Operations Quality, Post Market, Suppler Quality •Regulatory Strategy, Regulatory Submission, Clinical Evaluation, Sterilization, Biocompatibility, •Acquisition & Integration, Long/Short Term Strategy, Budgeting, Customer Management Industry Specific Expertise •cGMP, ISO 13485, 14971, MDSAP, MDD, MDR, IVDR, CFR Part 211, 210, 820, 814, 812, 56, 50, 4, 3 •510K, De Novo, PMA, Labeling, CE Marketing •Design Control, Validation, RI, SPC, KAIZEN, CAPA, NCRs, TDs, DfSS, DMAIC, DfR, GLP, GCP

Gopal Mohanty currently works in the Nervonik | Clarix Imaging | California State University Los Angeles |

No Languages Available

Gopal Mohanty has prior
experience in the following industries:
Integer Holdings | Advanced Energy | Danaher | Johnson And Johnson | Life Technologies | Boston Scientific | Baxter Healthcare | Ford Motor

Gopal Mohanty has the following professional experience:
Nervonik | Clarix Imaging | California State University Los Angeles | Integer Holdings | Advanced Energy | Danaher | Johnson And Johnson | Life Technologies | Boston Scientific | Baxter Healthcare | Ford Motor