Medical Affairs Manager - Integration and Risk Remediation

Roles & Responsibilities

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

Experience Required

• 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

Skills & Certifications

• 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

Eligibilities & 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%