Primary Function:
The Post Market team at Intuitive works at the intersection of Regulatory and Quality. The team processes complaints including meeting our global regulatory requirements. The post market team works cross-functionally to understand product safety and performance and facilitate the execution of robust resolutions. Functions collaborating with the Post Market Surveillance team include Field Action, Data Analytics, Clinical Engineering, Field Service, Technical Support, Customer Service, Risk Management, Service Operations, and Failure Analysis Engineering.
The Post Market Surveillance team requires an Analyst with post market surveillance experience and expertise in analyzing and processing medical device complaints. The position requires excellent verbal and technical writing skills, and passion for the best practices to analyze and process complaints.
Roles and Responsibilities:
- Reporting to the Supervisor, Regulatory Post Market Surveillance, the Regulatory Post Market Surveillance Analyst is responsible to:
- Perform the preliminary classification of complaints and escalate complaints that require additional review.
- Complete follow-up with the customer or reporter via phone and email to gather additional information required for complaint investigation, including retrieval of RMA
- Partner with subject matter experts on various activities related to complaint investigations, escalated field events, or regulatory response letters.
- Evaluate complaints for global regulatory reporting in accordance with company procedures and Regulatory requirements
- Review product analysis investigation and determine cause / contribution of event to device
- Accurately select Risk (Hazard, Harms, Severity) and IMDRF codes
- Escalate complaints that require additional review to product quality, manufacturing and design engineering teams as required
- Evaluate documentation for completeness and consistency and identify additional actions as necessary to close the complaint file.
- Approve final complaint file for closure after all applicable actions are completed
- Participate in new hire training and continuous Regulatory Compliance training as required
- Participate in process improvement activities to continuously improve process effectiveness
- Perform other duties as directed
Skills/Job Requirements:
Education: Undergraduate degree in engineering, life science, or equivalent
Experience – 5 + years of experience in medical device field, with experience in the following areas:
- Working understanding of regulatory post market requirements for Medical Devices, complaint system, and process requirements for post market surveillance.
- Working understanding of regulatory quality records requirements and how they apply to complaint files and regulatory reports.
- Working understanding of worldwide regulatory reporting requirements. (US FDA requirements, EU MDR requirements, etc.).
Training/Competencies:
- Understanding of world-wide regulatory reporting requirements for Medical Devices and complaint system and process requirements preferred
- Firm understanding of quality records requirements and how they apply to complaint files.
- Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.
The following skills are required for this position:
- Demonstrated strong written and verbal communication skills
- Strong computer skills (Excel, Word, PowerPoint, database)
- Excellent organizational and analytical skills
- Ability to handle and manage workload independently
- Prioritize numerous activities in a rapid paced environment
Working Conditions
This position requires the ability to complete most of the workday using a computer.
Intuitive is an Equal Employment 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.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
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 may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.