Coordinate and provide oversight in the analysis of PMS dataIdentify and escalate instances when products are not achieving the intended performance based upon anticipated levels of frequency and/or severityIdentify and evaluate new failure modes when encounteredMaintain procedures, as necessarySupport responding to requests for additional information from competent authorities, registries and notified bodiesWork cross-functionally with Quality, Regulatory, Clinical Affairs, and Operations departments to fulfill ad-hoc data requests and deliver detailed analysis of PMS dataDevelop and maintain knowledge of support systems including Master Control, JDEPerforms other related duties and responsibilities as assignedAbility to travel up to 5% of the timeQUALIFICATIONSRequired QualificationsApply project management tools to ensure reports are submitted based on the commitment timelinesAbility to make and present risk-based decisionsStrong interpersonal skillsProblem solving abilityAbility to create, review and coordinate reports based on established guidelines and regulatory requirementsOral and written presentation skillsAbility to provide analysis within strict timeline requirements and assuming accountability toward delivering on agreed upon commitmentsEducation and/or ExperienceRequires a minimum of a bachelor's degree, Engineering Degree, or degree in a technical field Proficient in Windows OS, Microsoft Office SuiteProficient in Excel in manipulation of dataPreferred Knowledge and Skills Medical device experience working with Class l, ll, and lll devicesExperience in technical writing and project managementAbility to develop & maintain dashboards using BI toolsPHYSICAL DEMANDSWhile performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. RESPONSIBILITIES Responsibilities include, however are not limited to: Work with a team to meet the requirements in generating periodic PMS related reports Participate in projects to align with BD Quality, MDD/MDR strategies and regulatory submissionsIdentify gaps and maintain PMS processes in compliance with global regulationsParticipate in PMS planning and reportingExtract and generate PMS and operational performance data necessary for generating applicable reports.