JOB DESCRIPTION At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered, and recognized.What You Can ExpectThe Post Market Surveillance Specialist is document owner for Post Market Surveillance Activities; will document PMS Plans and, if the case, PMS Reviews (PSURs or PMSRs) records according to the applicable regulations (including MDR (EU) 2017/745); he /she will be responsible for working with Regulatory Affairs to ensure documentation has been reviewed and aligned with Notified Body (when applicable). The PMS specialist will ensures Post Market Clinical Follow-up (PMCF) commitments are clearly documented within relative PMSPs, informed within clinical research department, and aligned with Notified Bodies. Scheduling and coordination of PMS teams for review of proactive and vigilance activities according to schedule; gathering inputs from cross functional stakeholders, and elevating at-risk findings to senior management. Track execution of PMS plans according to requirements; report to his / her manager on track, delayed and at risk PMS commitments; project management of PMS action items to ensure deadlines met. Completes routine audits of PMCF commitments against PMSPs to ensure quality and transparency of commitments is maintained.How You'll Create ImpactManaging writing, reviewing and maintenance of post market surveillance (PMS) assignments; including document ownership of initial PMS plans (PMSPs), revised plans, tracking of Post Market Clinical Follow-up (PMCF) commitments and scheduling of PMS reviews (Periodic Safety Update Reports (PSURs) and/or Post market Surveillance Reports (PMSRs) as outputs) according to the PMS schedule.Identify pertinent internal and external sources of clinical data for the Zimmer Biomet products necessary to fulfill the regulatory requirementsIn collaboration with other team members as applicable and as needed, performs sales data searches and analysis, literature and registry reviews as well as complaints trending, similar devices in DAEN and HHEs on the products in scope.Organize and lead PMS review meetingsBe accountable for getting PSUR / PMSR documents created, reviewed and approved in time as per plansSupport the Manager or Team Leader for Audit activities including the participation in Audits as clinical PMS SME as neededDelivers results, drives for continuous improvement. Holds him/herself accountable for the results expected. Acts with a sense of urgency.What Makes You Stand OutExcellent written and verbal communications skillsKnowledge of regulatory compliance for medical devicesDemonstrated project management skillsStrong ability to interpret and disseminate relevant product information for regulatory purposesUnderstanding of statistical methodsAbility to critically analyze and interpret scientific dataHave an analytic and strategic mindsetAbility to work within tight deadlines, adjust to changes in prioritiesAbility to function independentlyAbility to identify problems and research possible solutionsPossesses outstanding organizational skills, attention to detail and proofreading skillsTakes actions that are best for the company versus his or her individual unitEncourages and supports information sharing and collaboration across teams and departmentsDemonstrates sound business ethics; shows consistency among principles, values and behaviors.Your BackgroundEnglish proficiency is required (C1)Minimum of a Bachelor's degree or equivalent education in health, life sciences, engineering or a similar discipline required.Master and PhD degree preferred.Medical Device Functional Experience (Clinical, Post Market Surveillance, Engineering, Regulatory, Quality or equivalent).Knowledge of Medical Device Directive and MDR (EU) 2017/745Please note that you must submit your resume in English at the time of applying, or your application will not be considered.Travel ExpectationsEOE/M/F/Vet/Disability
