Profile Details

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Hire James B.

United States

USD 85 /hr

Post Market Surveillance Subject Matter Expert with 9+ years experience

Profile Summary

I am a Quality leader with an immense passion for continuous improvement and varied, extensive experience in the realm of Post Market Surveillance, NC/CAPA, and Risk Management. I have worked and managed all facets of complaint handling, including but not limited to, complaint intake, complaint investigation/failure analysis, MDR/MDVR adverse event reporting, ASR/PSR reporting, trending, and risk analysis. In addition to complaint handling, I have successfully built and implemented EU MDR processes, trained 100+ employees, managed and executed numerous NC/CAPAs/Field Actions, integrated complaint handling database/processes following acquisitions, and revised Risk Management Files for enhanced tracking & trending capabilities.

Subject Matter Expertise

• ★ Medical Devices
• ☆ Surveillance Systems
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Product Compliance

Services

• Consulting

Consulting Scientific and Technical Consulting, Regulatory Consulting

Work Experience

Director, Quality Systems

Flowonix Medical, Inc.

April 2021 - Present

Director, Post Market Surveillance

Flowonix Medical, Inc.

November 2019 - April 2021

Associate Manager, Post Market Surveillance

Stryker Spine

October 2018 - November 2019

Supervisor, Post Market Surveillance

Stryker Spine

January 2018 - October 2018

Supervisor, Product Surveillance

Allergan

June 2016 - December 2017

Lead Representative, Product Surveillance

Allergan

February 2015 - July 2016

Senior Representative, Product Surveillance

Allergan

November 2013 - February 2015

Representative, Product Surveillance

Allergan

April 2012 - November 2013

Education

BS Biopsychology

University of California Santa Barbara

August 2007 - May 2011

Certifications

• Certification details not provided.