Principal Regulatory Affairs Strategist

Company Description It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do  a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.

We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.

Job Description Primary Function of Position This is a principal-level individual contributor role responsible for early regulatory and clinical strategy for emerging surgical technologies. The Principal Regulatory Affairs Strategist works upstream with R&D, Clinical Affairs, Quality, Product, and business stakeholders to shape intended use, indications, claims, classification, evidence needs, regulatory pathway, and global market access strategy before submission plans are fully defined.

The role is focused on strategy, judgment, and senior-level advisory impact rather than day-to-day submission execution or post-market lifecycle ownership. The strategist develops practical US and OUS regulatory options for programs, guides clinical evidence strategy, and helps senior leaders understand the risks, trade-offs, and decisions needed to move technologies toward market authorization.

Essential

Job Duties Regulatory Strategy Develop and lead early regulatory strategy for the surgical platform and its product families — robotic and surgical systems, instruments, accessories, disposables, and their associated software and digital capabilities.

Shape product direction early in the product life cycle and advise on the regulatory consequences of intended use, indication, claims, classification, and design choices.

Develop regulatory strategies for both US and OUS markets.

Translate regulatory strategies into detailed, executable plans.

Advise senior leaders and cross-functional teams on regulatory risks, trade-offs, and decision points for programs with ambiguous pathways or significant clinical evidence needs.

Clinical Strategy Define the clinical evidence strategy needed to support regulatory authorization for novel or complex medical technologies, including evidence plans, study design logic, endpoint selection, comparator considerations, and related clinical adoption and market access considerations.

Lead or contribute to strategy for early clinical investigations, including US IDEs, EU clinical investigations, and other international study requirements that support product development, evidence generation, and market access.

Partner with Clinical Affairs and Clinical Operations to ensure early clinical investigations are planned and executed in a way that supports regulatory strategy, evidence needs, and market access goals.

Assess when feasibility evidence, pivotal evidence, or post-market data best serves a program, and defend that judgment with regulators, internal reviewers, and clinical stakeholders.

Qualifications Required Experience and Education Minimum 15 years of related regulatory affairs experience with a bachelor's degree; or 12 years with a master's degree; or a PhD with 8 years of experience; or an equivalent combination of…