Clinical Scientist III

Previous experience in the application of in-depth therapeutic and device knowledge to the development of Clinical Evaluation Plans and Reports.

Must have a minimum of 2-4 years of medical writing experience.

Strong experience in conducting literature searches, and review and appraisal of scientific data.

Strong experience in protocol development, writing clinical sections of documents for regulatory submission and clinical evaluation report writing.

Minimum of 0-2 years of experience in Clinical Evaluation Report (CER) writing in a medical device industry is preferred.

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

Mandatory Notices

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees
who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s
start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.

This position reports to Manager, Medical Sciences and requires a strong candidate with expertise in the analysis of medical literature, data from clinical trials and pre-clinical studies, and sound knowledge of applicable regulations and standards.

The position will mainly focus on the development of Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs), with a potential for future additional responsibility in the development of other clinical evidence documents.

The purpose of this job is to work collaboratively to develop strategies for the creation of CEPs followed by the development of CERs per EU MDR, to meet essential requirements in support of submission for CE Mark application to obtain Declaration of Conformity and EU market clearance, re-certification, and proposed indication/labeling changes.

Further, the responsibility includes the development of regular CEP and CER updates to maintain EU product conformance.

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 responses to the requests and questions on the clinical documentation from the regulatory authority.

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