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.

SKILL/JOB REQUIREMENTS:

• Education:
• B.S. or higher, preferably in Engineering or in a Science field
• Experience:
• Minimum 3 years relevant experience working in a medical device company (can be in combination with a regulatory degree; e.g., Masters in Regulatory Science) and/or applicable work for a regulatory agency
• Minimum 2 years of experience in submissions and technical documentation for medical devices
• Experience with new product development projects for complex products
• Skills:
• Ability to create 510(k) submissions, memo-to-files, and technical documentation for complex new products
• Understanding of design controls with experience in verification and validation methods and documentation
• Able to quickly learn third-party test requirements such as UL / IEC product testing, biocompatibility testing, sterilization
• Strong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions
• Good interpersonal skills and able to work well with cross-functional teams
• Good project management skills

• Prepare and submit sections of or complete 510(k)s (FDA) to obtain regulatory clearances for new products, new indications, and significant product changes in a timely manner.
• Prepare “Memo to File” documentation to support internal filings for product development projects and product changes not requiring regulatory agency approvals.
• Support product development teams on regulatory issues, including review of documentation.
• Provide insight on documentation issues and guide teams on regulatory requirements
• Support continuous improvement of the submission process in accordance with Intuitive Surgical Product Development Process.
• Work indirectly or directly or with regulatory agencies on regulatory issues and submissions.
• Support international regulatory efforts as needed.
• Perform other duties as required.