Future Forward Senior Nurse Lead, Medical Affairs (Finance)

Company Description
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
Job Description
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.

Base Salary Range Region 1: $167,300 USD - $240,700 USD
Base Salary Range Region 2: $142,200 USD - $204,600 USD
Shift: Day
Workplace Type: Remote - This job will be remote and/or the job is designed to be performed outside of the office. Employees will come onsite when requested by the leader.