Job Description

·         Work closely with investigation teams to identify, assess and track potential adverse events and/or field actions and escalate to Regulatory in a timely manner

·         Monitor new and revised regulatory requirements in the area of Regulatory Compliance and translate information into area processes

·         Participate and assist during audits and/or inspections as needed

·         Actively participate on Quality teams and cross-functional project teams as needed

·         Facilitate the evaluation of complaints, including assessment, investigation, containment, review, approval and determination of on-going needs

·         Ensure adequacy of complaint records (e.g. investigations, CAPA, NCs) Identifies, collects, trends, analyzes, and summarizes product quality data to identify product quality issues

·         Identifies product and process improvements to reduce complaints and cost of poor quality Promotes global awareness and provides training to policy and procedures

·         Provides support in the execution of field actions

·         Contributes to the establishment and maintenance of product risk management

·         Provides recommendations for business process improvements as they are identified during the analysis, tracking, and trending of quality review inputs

·         Provides management with status updates on assigned responsibilities and goals and escalates issues in a timely fashion

·         Other activities as assigned Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs. Requirements:  

·         2+ years recent experience in Quality/Regulatory Affairs in a in vitro diagnostics device or medical device preferred

·         Knowledge of U.S. FDA regulations of medical device/IVD adverse event and field action assessment, health hazard evaluation, product risk safety analyses, MDR/recall reporting,

·         IVD/Medical Device labeling requirements and 21 CFR 820 and process requirements Knowledge of Vigilance reporting to OUS regulatory agencies desired