Post Market Surveillance Specialist

Primary Function of PositionInvestigates customer complaints, makes an initial reporting decision, provides failure analysis letters, and ensures completeness and consistency of complaint and related documentation.Roles and ResponsibilitiesThis position has responsibility and authority for:Investigating complaints daily:Perform the preliminary classification of complaints and elevate as needed.Perform failure analysis investigation review and raise issues for further review.File Malfunction MDR Reports as identified.Escalate adverse events or incident reports to Level IV analysts as identified.Evaluate documentation for completeness and consistency, and assign actions as necessary to close the complaint file.Approve final complaint file for closure after all applicable actions are completed.Manage complaint workload to meet required backlog goals.Review and analyze lot documentation (DHRs) to determine if there are anomalies possibly related to reported product failures.Escalate complaints to the Regulatory Post Market Surveillance Manager or Lead when new failure modes are encountered.Escalate complaints to the Post Market Investigation group as required.Evaluate 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 RMA.Create customer response letters.Provide peer review and feedback of complaints and reports.Participate in new hire training and continuous regulatory compliance training as required.Participate in process improvement activities to continuously improve process effectiveness.Execute on projects as required.Perform other duties as directed.Skills and Job RequirementsEducationUndergraduate degree in engineering, life science, or equivalent.Experience2+ years of experience in medical device field, with exposure in:Knowledge of medical device complaint files and quality record documentation.Knowledge of regulatory reporting requirements for medical devices (US FDA, EU MDD, etc.).General technical and/or clinical medical device knowledge.SkillsThe following skills are required for this position:Strong written and verbal communication skills.Proficient computer skills (Excel, Word, PowerPoint, database).Efficient independent worker with ability to focus.Attention to detail.Strong cross‑functional communication skills, both email and in person.Excellent organizational and analytical skills.Ability to handle and manage workload independently.Prioritize numerous activities in a rapid‑paced environment.Contribute to team‑oriented tasks.Strong analytical skills.Strong interpersonal and decision‑making skills.Competency / TrainingThe following competencies are essential for this position:General understanding of regulatory reporting requirements for medical devices and complaint system and process requirements.General 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.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 role.Equal Opportunity StatementIntuitive 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.Legal ConsiderationsWe will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.#J-18808-Ljbffr

Government Careers

Show more