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Pradeep Gupta

Director of Medical Quality and Regulatory Compliance

Regulatory Affairs Specialist at Zimmer Biomet

Gainesville, Florida Area

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Pradeep Gupta's Email Addresses & Phone Numbers

Pradeep Gupta's Work Experience

Cincinnati Sub-Zero Products, Inc.

Director of Medical Quality and Regulatory Compliance

March 2010 to November 2012

Draeger Medical Systems, inc.

Manager Regulatory Affairs

November 2007 to March 2010

Gaymar Industries

Corporate Manager QA/RA

March 2005 to September 2007

Pradeep Gupta's Education

Wichita, Kansas

Indian Institute of Technology, Roorkee

Becholar of Science, Mechanical Engineering

1973 to 1977

Pradeep Gupta's Professional Skills Radar Chart

Based on our findings, Pradeep Gupta is ...

Values competence
Engaging
Scheduled

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Based on our findings, Pradeep Gupta is ...

52% Left Brained
48% Right Brained

Pradeep Gupta's Estimated Salary Range

About Pradeep Gupta's Current Company

Cincinnati Sub-Zero Products, Inc.

Frequently Asked Questions about Pradeep Gupta

What company does Pradeep Gupta work for?

Pradeep Gupta works for Cincinnati Sub-Zero Products, Inc.


What is Pradeep Gupta's role at Cincinnati Sub-Zero Products, Inc.?

Pradeep Gupta is Director of Medical Quality and Regulatory Compliance


What is Pradeep Gupta's personal email address?

Pradeep Gupta's personal email address is p****[email protected]


What is Pradeep Gupta's business email address?

Pradeep Gupta's business email addresses are not available


What is Pradeep Gupta's Phone Number?

Pradeep Gupta's phone (305) ***-*168


What industry does Pradeep Gupta work in?

Pradeep Gupta works in the Medical Devices industry.


About Pradeep Gupta

📖 Summary

Director of Medical Quality and Regulatory Compliance @ Cincinnati Sub-Zero Products, Inc. From March 2010 to November 2012 (2 years 9 months) Manager Regulatory Affairs @ Draeger Medical Systems, inc. From November 2007 to March 2010 (2 years 5 months) Corporate Manager QA/RA @ Gaymar Industries From March 2005 to September 2007 (2 years 7 months) Manager, Regulatory Affairs @ Baxter Healthcare Corporation Managing product approvals and certifications worldwide; Representing Regulatory Affairs in product development teams for compliance with applicable standards and regulatory requirements. Preparing Regulatory Strategies and access changes for Global Regulatory Impact. From November 2012 to March 2014 (1 year 5 months) Medina, NY 14103Regulatory Affairs Specialist @ Zimmer Biomet EU-MDR Support - Contract Position to prepare EU-MDR compliant documentation for Orthopedic Implantable devices to support CE Marking - Getting ready for Notified Body Audit prior to release the products. The documents also included Technical Documents (Technical File) as well as all supporting documents such as GSPR, DoC, Design and Development Documents, Manufacturing, Post Market Surveillance, and PMCF, etc... From August 2019 to March 2020 (8 months) Warsaw, Indiana, United StatesSr. Manager, Regulatory & Clinical Affairs @ Philips Healthcare/Invivo Corporation, Diagnostic Imaging Managing product approvals and registrations worldwide; Representing Regulatory Affairs in product development teams for regulatory requirements. Providing regulatory strategies, Managing Clinical Evaluations, and timely executions. From August 2014 to August 2019 (5 years 1 month) Gainesville, Florida AreaManeger, QA/RA @ DENTSPLY INTERNATIONAL Responsible for all aspects of FDA, Corporate Compliance and International Medical Device Regulations compliant Quality Management System development, implementation and enforcement for the design and manufacture of medical devices. Successfully directed Quality, Regulatory and Document Control departments at multiple locations. Developed and implemented policies/procedures managing ISO/GMP/QSR compliant facilities Reduced number of product inspections, streamlined inspection processes and performed vendor audits Managed sterilization process including validations and monitoring Directed product testing for safety and efficacy and prepared 510(k) submission documents  Prepared and submitted documents for product registration in foreign countries including China, Japan, and Taiwan  Worked closely and interacted effectively with Regulatory and inspection agencies to achieve successful results EMS Coordinator, ensured compliance with EPA and OSHA regulations including training, annual reporting and hazardous material From June 1997 to March 2005 (7 years 10 months) Des Plaines, IL


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Pradeep Gupta's Personality Type

Extraversion (E), Sensing (S), Feeling (F), Judging (J)

Average Tenure

3 year(s), 3 month(s)

Pradeep Gupta's Willingness to Change Jobs

Unlikely

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