[Hiring] Registered Nurse Medical Reviewer/Safety Reviewer III @Orion Group

Role Description

The Medical Reviewer/Safety Reviewer III reviews and assesses medical device adverse events and device deficiencies from clinical studies, performs medical assessments for post-market device cases, and supports medical device safety management in compliance with global regulations. A current RN license is required.

• Collect, review, assess, and process complaints and reports containing medical device adverse event and device deficiency information from clinical studies in a compliant and timely manner.
• Assess seriousness, labeling, causality, and follow-up data received to support compliance with global regulations.
• Perform medical assessments for post-market device portfolio cases as needed and escalate to the Medical Device Safety (MDS) physician when appropriate.
• Maintain an understanding of medical device and combination product risk management regulations, applicable standards, and guidance documents.
• Support and participate in audits and inspections as needed.
• Manage medical device safety workload and support higher-level safety activities, including workload prioritization, training, database reconciliation, and safety surveillance.
• Troubleshoot problems, identify issues, and escalate appropriately to the manager.
• Coach and mentor designated Medical Device Safety staff on assigned safety activities under the direction of the leadership team.
• Perform other duties as assigned to meet departmental needs and deliverables.

Qualifications

• Current Registered Nurse (RN) license is required.
• Four to seven years of medical device safety experience.
• Ability to critically evaluate medical data and escalate relevant information to Medical Device Safety physicians as appropriate.
• Bachelor's degree with a related health sciences background, such as a BSN, BS, or engineering degree. Candidates without the appropriate degree may be considered if they have previous medical device experience.
• Demonstrated ability to lead project work, build collaborative relationships across functions, and facilitate meetings, with proven success in results-driven process management.
• Proficiency with Windows, Microsoft Word, and Excel, and electronic document management systems (EDMS), such as Oracle/Clinical and OneTrack.
• Ability to accurately present medical data orally and in writing and assign tasks to others in the Medical Device Safety physician's absence.

Benefits

• Pay Rate: $45-50/hr (depending on candidate's location and medical benefits preference)
• Length of Assignment: 1 year
• 100% remote. Candidates must be located in the US and able to work without visa sponsorship.