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Field Action Specialist

Company: VirtualVocations
Location: South Bend
Posted on: October 29, 2024

Job Description:

A company is looking for a Field Action Specialist to support correction and removal activities in accordance with regulatory requirements.



Key Responsibilities:

Facilitate the Event Investigation Board, including meeting agendas and action item tracking
Maintain the master list of field actions and prepare reports for management review
Collaborate with stakeholders to ensure accurate preparation of field action documentation


Required Qualifications:

Bachelor's degree or equivalent in a related life science/technical discipline
5+ years of experience in a regulated manufacturing industry, with 2+ years in field action processes
Advanced knowledge of ISO 13485, 21 CFR 820, 806, 810, and MDSAP
Experience with device/drug/biotech manufacturing processes
Knowledge of (EU) 2017/746 (IVDR) preferred

Keywords: VirtualVocations, Elkhart , Field Action Specialist, Other , South Bend, Indiana

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