Post Market Surveillance Adverse Event AnalystFull-timeShift: DayWays of Working: Onsite - This job is fully onsite.Employee Type: EmployeeGlobal Job Level (HCM): Professional 3 (9)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 integral 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.Primary 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 decisions, 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.Investigating 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 emailPerform 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) 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 elevate trends and alert limits or process triggers of safety concerns to defined escalation path to communicate these concerns.Provide 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 criteriaComplete 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 directedSkills, Experience, Education, & Training:EducationDegree in life science (e.g. RN), engineering, or equivalent.Advanced English proficiency, both written and spoken.ExperienceMinimum 5+ 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 ******* for Complaint File managementGlobal regulatory medical device requirements for EU, MDSAP countries, and other related requirementsSkillsThe following skills are required for this position:Demonstrate strong written and verbal communication skillsEfficient independent worker with ability to focusDemonstrate cross functional communication skills in email and in personStrong analytical and Excellent organizational skillsAbility to handle and manage workload independentlyPrioritize numerous activities in a rapid paced environmentContribute to team-oriented tasksStrong interpersonal and decision-making skillsCompetency / TrainingThe 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.
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📌 Post Market Surveillance Adverse Event Analyst (Mexicali)
🏢 Intuitive
📍 Mexicali