プロフィール詳細

プロジェクトを作成

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James B.に依頼

United States

Post Market Surveillance Subject Matter Expert with 9+ years experience

プロフィール概要

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.

専門分野

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

サービス

• Consulting

Consulting Scientific and Technical Consulting, Regulatory Consulting

職務経験

Director, Quality Systems

Flowonix Medical, Inc.

4月 2021 - 現在

Director, Post Market Surveillance

Flowonix Medical, Inc.

11月 2019 - 4月 2021

Associate Manager, Post Market Surveillance

Stryker Spine

10月 2018 - 11月 2019

Supervisor, Post Market Surveillance

Stryker Spine

1月 2018 - 10月 2018

Supervisor, Product Surveillance

Allergan

6月 2016 - 12月 2017

Lead Representative, Product Surveillance

Allergan

2月 2015 - 7月 2016

Senior Representative, Product Surveillance

Allergan

11月 2013 - 2月 2015

Representative, Product Surveillance

Allergan

4月 2012 - 11月 2013

学歴

BS Biopsychology

University of California Santa Barbara

8月 2007 - 5月 2011

認定資格

• 認定資格の詳細は未入力です。