Regulatory Affairs Specialist - Multiport da Vinci

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 at

Intuitive

. As 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.

Serve as the primary regulatory representative on project and product core teams. The Regulatory Affairs Specialist works across the organization in supporting design control activities, US and Canada regulatory assessment and submissions, and liaises with global regulatory counterparts on a wide range of products.

Develop regulatory pathway for US FDA and Canada new product registration, support product development and manufacturing teams in providing regulatory input and oversight, including review of documentation and communicating applicable regulatory requirements.

Assess the impact of the product and process changes, determine regulatory pathways for US and Canada markets, and prepare the corresponding regulatory submission or internal documentation.

Author regulatory submissions for US FDA 510(k) premarket notifications, internal “Letters to File” and Health Canada registration, and lead the review process through clearance/approval, where applicable.

Gather information from international counterparts regarding submission pathways and impact of changes and support international counterparts in global regulatory submissions/approvals.

Create and maintain product summary technical file (STED).

Identify and convey requirements from applicable standards and guidance documents to project teams.

Provide leadership on documentation issues and mentor teams on requirements.

Continuous improvement of the submission process in accordance with Intuitive Surgical Product Development Process.

Work directly with regulatory agencies on regulatory issues and submissions.

Support international regulatory activities upon request.

Perform other duties as required.

Ability to work in a fast-paced environment and handle multiple projects simultaneously.

Ability to author and manage US FDA and Canada submissions and review processes.

Understanding of design controls with experience in verification and validation methods and documentation and their relevancy to regulatory assessments

Ability to quickly learn third-party test requirements such as UL / IEC product testing, biocompatibility, sterilization, etc.

Strong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions.

Ability to digest and convey information to project teams from regulators including regulations, guidance documents, and standards.

Ability to review and provide critical feedback on design documentation.

Ability to learn internal procedures and processes and implement on project teams.

Good interpersonal skills and ability to work well with cross-functional teams.

Good project management skills.

Typically requires a minimum of 5 years of related experience with a University degree; or 3 years experience and a Master’s degree; or a PhD without experience; or equivalent work experience.

None

RAPS - RAC Certification is a plus