Field Action Specialist

VirtualVocations
Irving, Texas, United States
Full-time

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 trackingMaintain the master list of field actions and prepare reports for management reviewCollaborate with stakeholders to ensure accurate preparation of field action documentationRequired Qualifications : Bachelor's degree or equivalent in a related life science / technical discipline5+ years of experience in a regulated manufacturing industry, with 2+ years in field action processesAdvanced knowledge of ISO 13485, 21 CFR 820, 806, 810, and MDSAPExperience with device / drug / biotech manufacturing processesKnowledge of (EU) 2017 / 746 (IVDR) preferred

4 hours ago
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