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100% REMOTEPAY: $47-$52/hrRead the overview of this opportunity to understand what skills, including and relevant soft skills and software package proficiencies, are required.REQUIRED:Must have current RN licensingPost market medical device experience in either medical assessment, complaint handling, post market reporting – preference is actual medical device assessmentHighly prefer knowledge of medical device regulations both US – EU MDR and globalPrefer experience in Veeva OneTrack and / or Vault QualityMedical assessment experience HIGHLY preferred4-7 years medical device safety experience minimumDemonstrated ability to lead project work, facilitate cross-collaborative relationships and facilitate meetings with proven success in results-driven process management PC proficiency (Windows, Word, Excel) and in EDMS (e.g., oracle/clinical, OneTrack)Critically evaluate medical data and escalate necessary information to Medical Device Safety Physicians as applicableAccurately and medically present data, both orally and in writing, with the ability to assign tasks to others in Medical Device Safety Physician's absence.Job Description:Collect, review, assess and process complaints/reports with medical device adverse event and device deficiency information clinical studies in a compliant and timely manner to comply with global regulations, which includes but not limited to seriousness assessment, labeling, causality, follow- up data receivedPerform medical assessments as needed for post-market device portfolio cases escalating as need to the MDS physicianMaintain understanding of medical device/combination product risk management regulations, as well as applicable standards, and guidance documentsSupports and participates in audits and inspections as neededWorkload responsibilities are primarily medical device safety management related and include some safety higher level functioning (e.g. prioritizing workload, training, reconciliation of databases, safety surveillance). xhyhwjd Troubleshoots problems. Problem solving involves identification of problems and proper escalation to managerMentor/teach others with directions from leadership team by coaching and mentoring designated Medical Device Safety staff on assigned medical device safety activitiesOther duties may be assigned based on the need or work requirement of the department deliverables

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