Perform medical assessments of adverse events associated with assigned post-market medical devices.
Review cases and apply clinical judgment to understand the reported harm and its significance.
Determine appropriate follow-up questions based on clinical findings.
Manage daily assignments through the OneTrack work-in-progress dashboard.
Review and follow relevant medical device regulations, quality procedures, and SOPs.
Collaborate with other nurses supporting the same product family.
Participate in daily Teams communications and weekly team discussions to review difficult cases and share information.
Coordinate with Post-Market Quality Assurance and the medical doctor assigned to the device family when additional guidance is required.
Support secondary product-family coverage when another team member is unavailable.
Active Registered Nurse (RN) License: Must hold an active RN license in the state where they reside and are employed.
An active license is mandatory; a previously held but inactive license is not acceptable.
MDs, LPNs, LVNs, and PharmDs are not eligible for this role.
Clinical Nursing Experience: Approximately 2-3 years of clinical nursing experience is expected.
Medical-surgical (med-surg) experience is valuable because candidates need to understand clinical harm and apply nursing judgment when assessing adverse events.
Hospital experience in areas such as quality, risk management, or adverse event reporting can strengthen a candidate's profile.
Medical Device Experience: At least 2 years of relevant medical device experience, particularly in adverse event assessment or complaint handling/MDR reporting.
Understanding of medical device regulations is essential.
Direct medical assessment of adverse events is the strongest fit.
Candidates with complaint handling, reporting, or related medical device quality experience may also be considered.
Medical Device Regulatory Knowledge: Candidates should have exposure to or knowledge of applicable global medical device regulations and standards, including FDA 21 CFR 803 (Medical Device Reporting), EU Medical Device Regulation (EU MDR), and relevant ISO standards.
Critical Thinking and Independence: Strong clinical judgment and critical-thinking skills.
Ability to apply nursing knowledge to assess reported harm.
Comfortable working independently with minimal direction.
Able to adapt to change and navigate situations where the information may be incomplete or unclear.
Direct experience conducting medical assessments of medical device adverse events.
Hospital-based quality, risk management, or adverse event reporting experience combined with medical device industry experience.
Complaint handling and MDR reporting experience.
Exposure to post-market surveillance, safety surveillance, database reconciliation, or inspection support.
Experience working in a regulated medical device environment.
Positive attitude, flexibility, adaptability, and comfort navigating ambiguity.
Education: A bachelor's degree in nursing or higher is listed as the preferred requirement.
The hiring team is open to candidates with an associate degree if they have a strong relevant background and experience.
A bachelor's degree in another field may also be considered alongside an RN qualification and relevant experience.
An active RN license remains mandatory regardless of educational background.
Spectraforce Technologies
Oct 13, 2026