Job Description

100% REMOTE

PAY: $47-$52/hr

REQUIRED:

• Must have current RN licensing
• Post market medical device experience in either medical assessment, complaint handling, post market reporting – preference is actual medical device assessment
• Highly prefer knowledge of medical device regulations both US – EU MDR and global
• Prefer experience in Veeva OneTrack and / or Vault Quality
• Medical assessment experience HIGHLY preferred
• 4-7 years medical device safety experience minimum
• Demonstrated 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 applicable
• Accurately 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 received
• Perform medical assessments as needed for post-market device portfolio cases escalating as need to the MDS physician
• Maintain understanding of medical device/combination product risk management regulations, as well as applicable standards, and guidance documents
• Supports and participates in audits and inspections as needed
• Workload 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). Troubleshoots problems. Problem solving involves identification of problems and proper escalation to manager
• Mentor/teach others with directions from leadership team by coaching and mentoring designated Medical Device Safety staff on assigned medical device safety activities
• Other duties may be assigned based on the need or work requirement of the department deliverables

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