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Job description
Post Market Clinical Follow up (PMCF) Specialist
Join to apply for the Post Market Clinical Follow up (PMCF) Specialist role at Intuitive
Base pay range
$97,600.00/yr - $140,400.00/yr
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.
Primary Function of Position
The Post‑market Clinical Follow‑up Specialist provides leadership and expertise for the development of execution of PMCF for new and existing Intuitive products. This individual will lead cross‑functional teams in the development of PMCF strategies, track progress of PMCF activities, and create PMCF documentation including the PMCF Plan and PMCF Evaluation Report. The role will require close partnership with cross‑functional teams including Regulatory Affairs, Post Market Surveillance, Product Quality, Clinical Affairs, Medical Affairs, and Global Access Value Economics.
Roles & Responsibilities
Lead the development of PMCF strategies with cross‑functional teams that consider both regulatory evidence needs and global clinical evidence plans.
Uses broad understanding of clinical evaluation, clinical research, post market surveillance, risk management and research methodologies to develop innovative evidence strategies that align with product needs and company objectives.
Create and maintain PMCF Plans as required.
Build relationships with key stakeholders and ensure clear understanding of responsibilities and deliverables for each PMCF activity.
Monitor PMCF activities to ensure progression according to plans.
Proactively manage scope and risk and communicate to leadership as required.
Lead the development of PMCF Evaluation Reports with cross‑functional teams.
Guide teams through resolution for most situations relating to PMCF development and reporting, including complex issues where in-depth analysis and evaluation are required.
Support product develop teams on issues relating to PMCF clinical evidence needs and strategies for CE marking.
Work independently to balance priorities and drive results with limited supervision.
Facilitate effective team collaboration by leading meetings, using software tools (e.g. Zoom, Box, Sharepoint), and developing dashboards and other communication tools.
Draft and assemble documentation as required for internal records and regulatory submissions.
File documentation in systems such as ACCS.
Provided Subject Matter Expertise in Internal and External Audits as needed
Participate in process improvement activities to continuously improve process effectiveness.
Other tasks and projects may be assigned as necessary.
Qualifications
Minimum Experience and Education
Undergraduate degree in engineering, life science, or equivalent with 4 years of related experience; advanced degree in a medical or scientific discipline preferred
Minimum Related Experience Includes
Knowledge and understanding of EU Medical Device Regulation (MDR) (2017/745/EU)
General technical and/or medical device knowledge
Medical/technical writing and data synthesis
Medical device clinical research and/or clinical data analysis
Preferred Experience Includes
Development of clinical evidence strategies
Clinical study reports and/or publications
Clinical evaluation of medical devices
Post market surveillance and/or safety monitoring
Skills
Ability to organize and lead meetings (in-person and remote)
Strong verbal and e‑mail communication skills (in person and remote)
Ability to work effectively with individuals from different backgrounds, functional areas, and/or cultures.
Strong technical writing and ability to draft technical documentation
Ability to understand statistical methods applied to clinical data
General computer skills (Excel, Word, PowerPoint, database)
Efficient independent worker with ability to focus
Ability to handle and manage workload independently
Prioritize numerous activities in a rapid paced environment
Contribute to team‑oriented tasks
Analytical skills and ability to understand technical data
Decision‑making skills
Fluent in English (written and spoken)
Travel
Travel up to 20%, including international travel
Additional Information
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.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
We provide market‑competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.
Base Salary Range Region 1: $114,800 - $165,200
Base Salary Range Region 2: $97,600 - $140,400
Shift: Day
Workplace Type: Purposeful Onsite - This job requires being onsite for leader‑defined events and activities which could be monthly/annually. Onsite frequency may increase based on business need.
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Worksite address
sunnyvale, CA, 94087, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.