Medical Affairs Manager – (Remote) Req Exp in neonatal vascular

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 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.

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

• 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

• 35 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

• 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

• RN NP PA or MD required

• Masters degree in a health-related field preferred

• Neonatal PICC certification VA-BC CRNI or comparable vascular access credential preferred

• Ability to travel 25%