Post Market Surveillance Adverse Event Analyst

OverviewCompany DescriptionAt Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible. Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let/'s advance the world of minimally invasive care.Primary FunctionPrimary Function of Position:The Regulatory Post Market Surveillance Adverse Event Analyst investigates customer complaints related to injury / adverse event / or death cases and makes reporting conclusions, files regulatory reports, and ensures completeness and consistency of complaint documentation. This role includes live telephone intake and documentation of death and injury events phoned in to Intuitive by company representatives and customers. The AE Analyst is responsible for the actions or review of the complaint from intake through closure.ResponsibilitiesInvestigating serious injury / adverse event and death complaints dailyPerform the preliminary classification of complaints including reportability triage and decision makingConduct complaint investigations including following up with surgeons and other health care professionals via phone and emailAnswer live, incoming phone calls for Adverse Events from Customer Service, Technical Service, Intuitive Representatives and hospital site contacts (e.g., surgeons, physicians, operating room personnel). Collect in-depth information as available, and document complaint into the CRM systemPerform reportability determinations in conjunction with medical safety officer, as necessaryProvide input to clinical conclusion to be included in the complaint file and regulatory reportsEscalate complaints that require additional review to engineering, medical safety officer, clinical development engineering, etc.Accurately select Risk (Hazard, Harms, Severity, matching Clinical Risk Assessment line item) and IMDRF codesReview product analysis investigation and determine cause / contribution of event to deviceDraft and file medical device and vigilance ReportsEvaluate documentation for completeness and consistencyApprove final complaint file for closure after all applicable actions are completedManage complaint workload to required timeliness and goalsCollaborate with internal teams including clinical development engineering, human factors, medical safety office, risk management, engineering, and other departments as needed to provide relevant and critical clinical information related to adverse eventsAdherence to standard operating procedures and guidance documents across the organization for reporting, investigation and compliance related to post market requirementsAnalyze complaint data to identify trends, issues, or systemic discrepanciesRecognize and escalate trends and alert limits or process triggers of safety concerns to defined escalation path to communicate these concernsProvide the risk management team required data to support and incorporate new failure modes into risk management filesCollaborate with the Medical Safety Office to support monitoring activities and ensure timely escalations.Collaborate with the Intuitive Legal Department for legal claimsEnsure compliance to post market surveillance processes for regulatory database searches, literature reviews, surveys, and other proactive surveillanceAssess product relationship to reported complaints to root causeAlign to standard regulatory reporting assessment criteriaCollaborate on responses for Regulatory Agency Requests for additional information as assignedRepresent Post Market Surveillance at selected cross functional meetingsProvide monthly, daily, weekly reporting of key metrics and action plansDrive the progress of complaints throughout the complaint lifecycle to ensure proper documentation and timely closure of each complaintParticipate in internal and external auditsDevelop and maintain product knowledge of existing and new productsMaintain awareness of new or revised regulations and/or guidelinesProvide peer review and feedback of complaints and reportsParticipate in new hire training and continuous Regulatory Compliance training as requiredParticipate in process improvement activities to continuously improve process effectivenessExecute on projects as requiredPerform other duties as directedQualificationsSkills, Experience, Education, & Training:Minimum Undergraduate degree, preferably in life science (e.g., RN, engineering), or undergraduate degree with post-market surveillance experience.Operating Room, Surgical, Critical Care experience preferred.Minimum 3+ years of experience in medical device field, with experience in the following areas:Working knowledge and understanding of the FDA 21 CFR part 803 Medical Device Reporting and part 820.198 for Complaint File managementGlobal regulatory medical device requirements for EU, MDSAP countries, and other related requirementsSkills - The following skills are required for this position:Effectively prioritize / multi-task numerous activities in a rapid paced environmentDemonstrate exceptional written and verbal communication skillsEffective computer skills (Excel, Word, PowerPoint, database query)Efficient at autonomously working with ability to focusAttention to detailDemonstrate cross functional communication skills in email and in personDemonstrate customer service based phone communication skills / obtain event details live from varied disciplines (hospital personnel, Intuitive representatives) in a professional mannerProven analytical and Excellent organizational skillsAbility to handle and manage workload autonomouslyContribute to team-oriented tasksExcellent interpersonal and decision-making skillsCompetency / Training - The following competencies are essential for this position:Firm understanding of Regulatory reporting requirements for Medical Devices and complaint system and process requirements including good documentation practices and quality system elements.Firm understanding of quality records requirements and how they apply to complaint files.Familiarity with world-wide regulatory reporting requirements.Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.Additional InformationDue 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 tuitive 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.We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.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 salary ranges are listed.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 tuitive 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 NoticesWe 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 Compensation Range Region 1: $45 USD - $65 USDBase Compensation Range Region 2: $39 USD - $55 USDShift: DayWorkplace 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. #J-18808-Ljbffr

Created: 2025-09-26