Senior Clinical Scientist

1w1 week ago

Intuitive

Bengaluru, IN · Full-time · INR 3,000,000 – INR 5,000,000

About this role

Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, with technologies like the da Vinci surgical system and Ion transforming patient outcomes worldwide. The Senior Clinical Scientist develops Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) per EU MDR to support CE Mark applications. This ensures EU market clearance, re-certification, and labeling changes.

Day-to-day work centers on analyzing medical literature, clinical trial data, and pre-clinical studies. Author key CEP sections and full CER documents, plus responses to regulatory authority questions. Manage CEP/CER timelines using project management tools for product development teams.

Interact with cross-functional teams in engineering, product development, regulatory, and post-market surveillance to plan CEP and CER strategies. Perform comprehensive literature searches and provide product guidance to clinical librarians. Review and critically appraise scientific literature for clinical summaries.

Join engineers, clinicians, and innovators united to make surgery smarter, safer, and more human. Solve challenging problems with creativity, rigor, and collaboration. Contribute to meaningful work that improves precision and recovery for patients globally.

Requirements

Expertise in the analysis of medical literature, data from clinical trials and pre-clinical studies
Sound knowledge of applicable regulations and standards including EU MDR
In-depth knowledge of therapeutic areas, competitor devices, current clinical/market developments
Ability to perform comprehensive literature searches and stay informed about clinical landscapes and trends
Experience interpreting and summarizing published data to support risk assessment
Skills in critically appraising scientific literature for clinical summaries
Proficiency in proofreading, editing, document formatting, and review comment integration

Responsibilities

Interact with internal cross-functional teams (engineering, product development, regulatory, post-market surveillance) to define and plan the strategy for the development of CEPs and CERs for new products requiring CE Mark
Develop and author clinical documentation for regulatory submissions, mainly key sections of the CEP, and the entire CER document
Develop and author responses to the requests and questions on the clinical documentation from the regulatory authority
Participate in and/or perform comprehensive literature searches to develop and maintain in-depth knowledge of current scientific literature
Provide product guidance and expertise to the clinical librarian to facilitate conducting literature searches on products/product families
Review scientific literature and interpret and summarize published data on risks, alternate therapies and device-specific benefits
Critically appraise scientific literature and write clinical summaries for products and surgical procedures
Manage CEP/CER timelines required by product development teams and global Regulatory Bodies by utilizing appropriate project management tools