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Job description
Job Summary
This role supports Medical Affairs integration activities for a newly acquired product portfolio, focused on remediating claims, labeling, evidence, and risk documentation for vascular access products used in neonatal and pediatric care settings. The individual also provides ongoing Medical Affairs support for life cycle activities within the Advanced Access Devices (AAD) Medical Affairs team, applying clinical judgment and neonatal vascular access expertise to make risk-based recommendations when data are incomplete or evolving.
Roles & Responsibilities
Assess legacy clinical evidence, claims, and labeling against current clinical/regulatory standards
Identify gaps, unsupported claims, and potential patient safety risks
Apply neonatal vascular access expertise to evaluate product performance and evidence gaps for NICU devices (neonatal PICCs, peripheral IVs, UVCs, UACs, NG feeding tubes, urinary drainage catheters)
Provide clinical recommendations to remediate claims, promotional messaging, IFUs, labeling, training materials, and risk management documentation
Contribute clinical input to integration decisions impacting product design, intended use, and risk profile
Support human factors activities through task analysis review and clinical accuracy assessments
Integration & Remediation (Primary Focus)
Assess legacy clinical evidence, claims, and labeling against current clinical/regulatory standards
Identify gaps, unsupported claims, and potential patient safety risks
Apply neonatal vascular access expertise to evaluate product performance and evidence gaps for NICU devices (neonatal PICCs, peripheral IVs, UVCs, UACs, NG feeding tubes, urinary drainage catheters)
Provide clinical recommendations to remediate claims, promotional messaging, IFUs, labeling, training materials, and risk management documentation
Contribute clinical input to integration decisions impacting product design, intended use, and risk profile
Support human factors activities through task analysis review and clinical accuracy assessments
Sustaining and Life cycle Support (Secondary Focus)
Provide Medical Affairs input to design changes and life cycle management activities
Support complaint review, clinical signal evaluation, and field actions
Review/provide clinical input on claims development, neonatal vascular access procedures, clinical algorithms, competency requirements, and bedside workflow considerations
Cross-Functional Leadership
Serve as Medical Affairs representative across Regulatory Affairs, Quality, R&D, and Marketing
Translate clinical evidence into design, regulatory, and commercial decision-making
Ensure claims/materials are clinically appropriate and evidence-based
Provide risk-based recommendations grounded in patient safety and regulatory expectations
Risk & Evidence Development
Develop/maintain clinical content for risk management documentation (hazard analyses, benefit‑risk assessments)
Support literature reviews, evidence generation, and clinical content for regulatory submissions
Respond to medical inquiries per regulatory/company requirements
Support neonatal‑focused evidence reviews on vascular access indications, device selection, insertion/maintenance practices, complications, and outcomes
Experience
Minimum 5 years of clinical experience; direct neonatal, NICU, or pediatric vascular access experience strongly preferred
Hands‑on experience with neonatal vascular access assessment, device selection, placement support, maintenance, troubleshooting, and complication recognition
3-5 years of Medical Affairs or Clinical Affairs experience supporting medical devices - preferred
Experience reviewing/contributing to risk management documentation (hazard analyses, FMEAs, benefit‑risk assessments, complaint evaluations, post‑market surveillance) - preferred
Experience with claims development, labeling, or risk documentation in a regulated environment - preferred
Advanced vascular access experience with neonatal PICCs, peripheral IVs, extended dwell peripheral catheters, UVCs, UACs, or related devices - preferred
Experience supporting product integration, remediation, or due diligence activities - preferred
Experience working cross‑functionally with Regulatory Affairs, Quality, and Safety teams - preferred
Current or prior NICU vascular access team experience - preferred
Key Skills
Strong understanding of neonatal vascular access risks (infiltration, extravasation, catheter‑related infection, thrombosis, malposition, skin injury, vessel preservation)
Critical thinking and clinical judgment in ambiguous situations
Excellent written and verbal communication
Cross‑functional collaboration in fast‑paced, matrixed environments
Familiarity with risk management frameworks and safety reporting requirements
Working knowledge of FDA and/or EU MDR requirements
Eligibility & Qualifications
RN, NP, PA, or MD required
Master's degree in a health‑related field - preferred
Neonatal PICC certification, VA-BC, CRNI, or comparable vascular access credential - preferred
Ability to travel 25%
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Worksite address
sandy, UT, 84092, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.