Post Market Clinical Follow up (PMCF) Specialist

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 employeeswho 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 governments 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 employeesstart 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.

Remote Work :

No

Employment Type :

Full-time