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 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.
Job Description
Primary Function of Position
The Regulatory Affairs Specialist supports the department by converting/creating the Medical Device Technical Documentation according to the India Medical Device Rules, evaluating medical device changes, determining and executing registration strategy and ensuring compliance of marketing material according to internal processes
Essential Job Duties
Prepares and submits medical device technical documentation according to India Medical device rules requirements
Assesses the regulatory impact on the development of recent devices or the changes to existing products
Coordinates registration strategy with sales/marketing stakeholders
Prepares and submits Medical Device registration dossiers for assigned geographies and ensures accurate records
Replies regulatory inquiries to key stakeholders (e.g. Customer Service, Contract/Tender, Sales)
Performs regulatory review of marketing material (e.g. brochures, presentations) for compliance to assigned geographies reg