About the position

Promotes patient safety through ability to independently review patient safety-related data from medical device/combination products in clinical trials or as part of post-market surveillance. The primary responsibility is to assess the content, quality, and adherence of data to regulatory requirements and protocols by analyzing, triaging, and assessing Adverse Events and device deficiency information, as this position impacts patient safety, product approval, and safety signal identification.

Responsibilities

• 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
• Participate in investigation activities for departmental assigned child-task quality record investigation for device failures and human factors-related use errors
• Create narratives of serious adverse events and other identified events of interest in accordance with accepted standards and with a high degree of competency
• 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
• Develop cross functional relationships and effectively communicate with internal and external partners
• 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

Requirements

• Minimum: Bachelor's degree with related health sciences background BSN, BS, or Engineering
• Candidates lacking the appropriate degree but with previous medical device experience may be considered
• 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