Post Market Clinical Follow up; PMCF Specialist

Post Market Clinical Follow up (PMCF) Specialist

Join to apply for the Post Market Clinical Follow up (PMCF) Specialist role at Intuitive

$97,600.00/yr - $/yr

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.

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.

• 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.

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…