Primary Function of PositionThe Regulatory Post Market Surveillance Specialist investigates customer complaints, makes an initial reporting decision, provides failure analysis letters, and ensures completeness and consistency of complaint and related documentation.Essential Job DutiesInvestigating complaints daily:Perform the preliminary classification of complaints and escalation complaints that require additional review.Perform Failure Analysis investigation review and escalation complaints that require additional review.File Malfunction MDR Reports as identifiedEscalate Adverse Event or Incident reports to Level IV Analysts as identifiedEvaluate documentation for completeness and consistency and assign additional actions as necessary to close the complaint file.Approve final complaint file for closure after all applicable actions are completed.Manage complaint workload to required backlog goals.Review and analyze lot documentation (DHRs) to determine if there are any anomalies that maybe related to reported product failures.Escalate complaints to the Regulatory Post Market Surveillance Manager or Lead when new failure modes are encounteredEscalate complaints to the Post Market Investigation (PMI) group as requiredEvaluate complaints for reporting requirements in accordance with company procedures and Regulatory requirements.Interface with Customer Service and hospitals to gather additional information required for complaint investigation,



including retrieval of RMACreate customer response lettersProvide 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 effectivenessQualificationsRequired Education and TrainingEducation - degree in engineering, life science, or equivalentEnglish proficiency required: 85% (spoken and written).
Experience – 2+ years of experience in medical device field, with experience or exposure in the following areas:Knowledge and understanding with Medical Device Complaint files and quality record documentationKnowledge and understanding of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDD requirements, etc.)General technical and or clinical medical device knowledgeWorking ConditionsNonePreferred Skills and ExperienceDemonstrate strong written and verbal communication skillsStrong computer skills (Excel, Word, PowerPoint, database)Efficient independent worker with ability to focusAttention to detailDemonstrate cross functional communication skills in email and in personExcellent organizational and analytical skillsAbility to handle and manage workload independentlyPrioritize numerous activities in a rapid paced environmentContribute to team-oriented tasksStrong analytical skillsStrong interpersonal and decision-making skillsGeneral understanding of Regulatory reporting requirements for Medical Devices and complaint system and process requirementsGeneral understanding of quality records requirements and how they apply to complaint filesAble to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary#J-*****-Ljbffr

📌 Post Market Surveillance Specialist (Mexicali)
🏢 Intuitive Surgical, S. De R. L De C. V.
📍 Mexicali