Post Market Clinical Follow up (PMCF) Specialist jobs in United States
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Intuitive · 5 hours ago

Post Market Clinical Follow up (PMCF) Specialist

Intuitive is a global leader in robotic-assisted surgery and minimally invasive care. The Post-market Clinical Follow-up Specialist will provide leadership and expertise in developing and executing PMCF strategies for Intuitive products, collaborating closely with cross-functional teams to ensure compliance and effectiveness in clinical evidence gathering.

Health CareManufacturingMedical Device
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Growth Opportunities
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H1B Sponsor Likelynote

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

Qualification

EU Medical Device RegulationMedical device clinical researchClinical evaluation strategiesData synthesisPost market surveillanceTechnical writingAnalytical skillsFluent in EnglishDecision-making skillsCommunication skillsTeam collaboration

Required

Undergraduate degree in engineering, life science, or equivalent with 4 years of related experience; advanced degree in a medical or scientific discipline preferred
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
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 up to 20%, including international travel

Preferred

Development of clinical evidence strategies
Clinical study reports and/or publications
Clinical evaluation of medical devices
Post market surveillance and/or safety monitoring

Benefits

Market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity

Company

Intuitive

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Intuitive designs and manufactures robotic-assisted surgical systems.

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 Company
Total Funding
$5M
Key Investors
St. Cloud Capital
2003-04-30Post Ipo Equity
2000-06-23IPO
1996-01-01Seed· $5M

Leadership Team

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Craig Child
Sr. Vice President, Human Resources
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Gillian Duncan
Senior Vice President, Professional Education & Program Services - Worldwide
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Company data provided by crunchbase