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 lifecycle 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. This is a remote role with a 12-month duration and flexible timezone; requires 10-panel drug screening.
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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 Lifecycle Support (Secondary Focus)
- Provide Medical Affairs input to design changes and lifecycle 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
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- 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
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- 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