Future Forward Senior Nurse Lead, Medical Affairs

The Senior Safety Nurse plays a mission-critical role at the intersection of clinical practice medical information exchange global regulatory compliance and risk management. This role provides strategic leadership and operational support to ensure patient safety clinical accuracy and product risk mitigation across the global device portfolio especially in emerging and developing markets. As a core member of the Future Forward Global Medical Affairs team the Senior Safety Nurse will deliver structured oversight across post-market surveillance global safety communications regulatory documentation and internal training aligned with FDA EUMDR ANVISA and other international standards.

KEY RESPONSIBILITIES:

Medical Affairs Strategy Development & Implementation

• Design and implement Medical Affairs inquiry intake triage documentation and archival systems in alignment with regulatory guidance (e.g. 21 CFR 820.198).
• Collaborate cross-functionally with Legal Regulatory Quality and Clinical teams to ensure harmonized compliant safety communication.
• Develop and maintain global SOPs and FAQ content related to product safety off-label use and procedural risks.

Clinical Safety & Risk Communication

• Serve as a global clinical liaison for safety-related inquiries from HCPs internal stakeholders and field-based teams.
• Respond to adverse events product questions and procedural risks with evidence-based regulatory-aligned communications.
• Conduct literature reviews and analyze post-market field data to inform labeling updates training initiatives and risk stratification.

Evidence Generation & Real-World Data Integration

• Aggregate and interpret clinical and real-world evidence to inform internal and external safety narratives.
• Maintain and expand a centralized clinical literature and evidence repository including customer-facing bibliographies and internal research tools.

Post-Market Surveillance & Regulatory Documentation

• Collaborate with Product Surveillance and Regulatory Affairs on adverse event assessments complaints and health hazard evaluations.
• Contribute to the development and review of Clinical Evaluation Reports (CERs) Health Hazard Assessments (HHAs) and annual safety reports.
• Provide ongoing support for global regulatory processes recalls and safety trend signal detection.

Internal Training & Global SOP Support

• Develop and deliver internal education on clinical risks safety messaging procedural indications and complaint handling.
• Review and align global physician training materials and internal documentation with approved product labeling and indications for use.

Clinical Trial & Data Monitoring

• Act as the designated safety monitoring nurse for Sponsor-Initiated Trials including adverse event adjudication through Electronic Data Capture (EDC) platforms.
• Summarize and contribute to annual safety reports submitted to regulatory agencies.

Cross-Functional Insight & Product Development

• Provide real-world clinical insight to R&D and Product Development to enhance product design risk controls and labeling strategy.
• Identify and assess opportunities for innovation in product safety procedural techniques and educational outreach.

Qualifications :

REQUIRED QUALIFICATIONS:

• Registered Nurse (RN) with active licensure.
• Bachelor of Science in Nursing (BSN) preferred; Associate Degree in Nursing acceptable with extensive clinical and regulatory experience.
• Minimum 5 years in Medical Affairs clinical safety or related field ideally in a global device or pharmaceutical organization.
• Deep working knowledge of 21 CFR 820 ISO 14971 and international regulatory frameworks (EUMDR TGA ANVISA).
• Demonstrated success in cross-functional collaboration and managing complex multi-stakeholder projects.

PREFERRED SKILLS & ATTRIBUTES:

• Proven ability to write and review clinical safety documents and SOPs.
• Familiarity with medical information platforms and CRM tools (e.g. Veeva Salesforce Health Cloud).
• Strong oral and written communication skills with experience presenting to internal and external audiences.
• Experience as a clinical educator product trainer or safety communication lead.
• Highly organized results-driven and comfortable in a fast-paced innovation-driven environment.
• Travel requirement: up to 25%.

FTE ALLOCATION MODEL:

• Medical Information & Field Support 30%
• Regulatory & Safety Documentation 20%
• Post-Market Surveillance & Quality Collaboration 20%
• Internal Training & SOP Development 15%
• Clinical Trial & Evidence Support 15%

Additional Information :

Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.

Mandatory Notices

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.

We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.

Remote Work :

No

Employment Type :

Full-time