Intuitive · 2 days ago
Senior Clinical Scientist
Sunnyvale, CA
Full-time
Hybrid
Senior Level
$144K/yr - $208K/yr
5+ years expIntuitive is a pioneer and market leader in robotic-assisted surgery, dedicated to minimally invasive care. The Senior Clinical Scientist will focus on developing Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) to support regulatory submissions and ensure product compliance with EU standards.
Health CareManufacturingMedical Device
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
Possess or acquire in-depth knowledge of therapeutic areas, competitor devices, current clinical/market developments, literature review processes and the ability to keep abreast of current literature
Participate in and/or perform comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies; stay informed about applicable clinical landscapes and trends
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; collect and summarize primary data to support risk assessment
Critically appraise scientific literature and write clinical summaries for products and surgical procedures
Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities
Manage CEP/CER timelines required by product development teams and global Regulatory Bodies by utilizing appropriate project management tools
Serve as the SME and/or functional representative for R&D development activities (e.g., Product or Technology Development Process teams) and support broader Clinical/Medical Affairs activities such as Regulatory submissions/responses
Perform periodic reviews of risk documentation and product labeling; ensure appropriate updates are implemented
Provide clinical perspective and support and guide new product development for CE Mark purposes. May require participation in ongoing core team activities (e.g., weekly meetings) or provide periodic participation and input as needed
Support the clinical affairs (CA) team with the creation of clinical content for other documents including Investigator brochures, manuscripts, scientific abstracts, conference presentations, and posters based on Intuitive clinical trials
Support the CA team with the development and writing of clinical study protocols and Clinical Study Reports (CSRs)
Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines)
Qualification
Required
Previous experience in the application of in-depth therapeutic and device knowledge for the development of clinical evaluation plans and reports
Ability to identify critical information needs and identify roles / individuals to involve in the decision-making process within clinical evaluation assessment and report development
Strong experience in conducting literature searches, and review and appraisal of scientific data
Expertise in clear and effective oral and written communication and in technical or scientific writing
A minimum of 5 -8 years of medical writing experience
Excellent critical thinking and analytical skills
A high level of attention to detail and accuracy
Ability to work effectively with cross-functional teams
Ability to manage multiple projects across numerous surgical disciplines
Strong communication, presentation and interpersonal skills with high attention to detail and organization
Strong experience in protocol development, writing clinical sections of documents for regulatory submission and clinical evaluation report writing
Ability to learn quickly and self-educate on different surgical specialties as applicable to medical products and procedures (Self-starter attitude)
Consistent dedication and strong work-ethics to meet aggressive timelines and simultaneous management of multiple projects, when necessary
MD, PhD or M.S. degree in a scientific field
Preferred
Minimum of 2-4 years of experience in clinical evaluation report writing in medical device industry is preferred
Company
Intuitive
Intuitive designs and manufactures robotic-assisted surgical systems.
10001+ employees
H1B Sponsorship
Intuitive has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (339)
2024 (238)
2023 (181)
2022 (285)
2021 (145)
2020 (138)
Funding
Current Stage
Public CompanyTotal Funding
$5MKey Investors
St. Cloud Capital
2003-04-30Post Ipo Equity
2000-06-23IPO
1996-01-01Seed· $5M
Leadership Team
Craig Child
Sr. Vice President, Human Resources
Gillian Duncan
Senior Vice President, Professional Education & Program Services - Worldwide
Recent News
2025-12-11
2025-11-14
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