Medical Affairs Manager Integration and Risk Remediation (Contingent) Role Summary
This role supports Medical Affairs integration activities for a newly acquired product portfolio, with a primary focus on remediation of claims, labeling, evidence, and risk documentation for vascular access products used in neonatal and pediatric care settings.
The individual will also provide ongoing Medical Affairs support for lifecycle activities. This role operates 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 and escalating issues as appropriate.
Key Responsibilities 1. Integration & Remediation (Primary Focus)
- Assess legacy clinical evidence, claims, and labeling against current clinical and regulatory standards.
- Identify gaps, unsupported claims, and potential patient safety risks.
- Apply neonatal vascular access expertise to evaluate product performance, patient safety considerations, and evidence gaps for devices used in NICU settings, including:
- Neonatal PICCs
- Peripheral IVs
- Umbilical venous catheters (UVCs)
- Umbilical arterial catheters (UACs)
- Nasogastric (NG) feeding tubes
- Urinary drainage catheters
- Provide clinical recommendations to remediate:
- Claims and promotional messaging
- Instructions for Use (IFUs), labeling, and training materials
- Clinical content within risk management documentation
- Training and educational materials
- Contribute clinical input to integration decisions that impact product design, intended use, and risk profile.
- Support human factors activities through task analysis review and clinical accuracy assessments.
2. 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 as needed.
- Review and provide clinical input on:
- Claims development and review
- Neonatal vascular access procedures
- Clinical algorithms
- Competency requirements
- Bedside workflow considerations
3. Cross-Functional Leadership
Serve as the Medical Affairs representative across Regulatory Affairs, Quality, R&D, and Marketing functions by:
- Translating clinical evidence into design, regulatory, and commercial decision-making.
- Ensuring claims and supporting materials are clinically appropriate and evidence-based.
- Providing clear, risk-based recommendations grounded in patient safety and regulatory expectations.
4. Risk & Evidence Development
- Develop and maintain clinical content for risk management documentation, including hazard analyses and benefit-risk assessments.
- Support literature reviews, evidence generation activities, and clinical content development for regulatory submissions.
- Respond to medical inquiries in alignment with regulatory and company requirements.
- Support neonatal-focused evidence reviews related to vascular access indications, device selection, insertion and maintenance practices, complications, and patient safety outcomes.
Key Deliverables
- Clinical gap assessments for the integrated product portfolio.
- Claims and labeling remediation recommendations.
- Clinical content for risk management documentation.
- Literature reviews supporting claims substantiation and regulatory activities.
- Contributions to clinical sections of regulatory submissions and regulatory responses.
- Neonatal vascular access clinical rationale supporting claims, labeling, IFU updates, training content, and risk remediation decisions.
Required Qualifications
- RN, NP, PA, or MD required.
- Master's degree in a health-related field preferred.
- Minimum of 5 years of clinical experience, with 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.
- Strong understanding of neonatal vascular access risks, including infiltration, extravasation, catheter-related infection, thrombosis, malposition, skin injury, and vessel preservation principles.
- Strong critical thinking skills with the ability to apply clinical judgment in ambiguous situations.
- Excellent written and verbal communication skills.
- Ability to work effectively in a fast-paced, matrixed environment.
- Ability to travel 25%.
Preferred Qualifications
- 3-5 years experience in Medical Affairs or Clinical Affairs supporting medical devices.
- Experience reviewing or contributing to risk management documentation (e.g., hazard analyses, FMEAs, benefit-risk assessments, complaint evaluations, post-market surveillance activities).
- Experience with claims development, labeling, or risk documentation in a regulated environment.
- Advanced vascular access experience with neonatal PICCs, peripheral IVs, extended dwell peripheral catheters, UVCs, UACs, or related devices.
- Experience supporting product integration, remediation, or due diligence activities.
- Experience working cross-functionally with Regulatory Affairs, Quality, and Safety teams.
- Familiarity with risk management frameworks and safety reporting requirements.
- Working knowledge of FDA and/or EU MDR requirements.
- Current or prior NICU vascular access team experience.
- Neonatal PICC certification, VA-BC, CRNI, or a comparable vascular access credential preferred.