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.Job DescriptionPrimary 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.Perform the preliminary classification of complaints and escalates complaints that require additional review.Perform Failure Analysis investigation review and escalates 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 skillsEfficient independent worker with ability to focusDemonstrate 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 necessaryAdditional InformationShift: Day#J-*****-Ljbffr