Registered Nurse Medical Reviewer/Safety Reviewer III - Medical Device Safety and Adverse Events

Registered Nurse Medical Reviewer/Safety Reviewer III - Medical Device Safety and Adverse Events

Location: 100% remote. Candidates must be located in the US and able to work without visa sponsorship.

Length of Assignment: 1 year

Pay Rate: $45-50/hr (depending on candidate’s location and medical benefits preference)

Job 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.

People are our business worldwide

Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.