Bucharest, ROM
7 days ago
Post Market Surveillance Senior Specialist
We are looking for a **Post Market Surveillance Senior Specialist** to join our PMS EMEA team in Bucharest. **What you will do:** + ExecutePMSactivitiesinlinewithdefinedproceduresandprocesses. + Implement post market strategy and processes for handling recalls and communicationtostakeholders(e.g.HCP,patient,distributor,andhealthauthorities) + Reportproductsafetyissuestoregulatoryauthoritiesasrequired,tocomplywith local, regional and global regulations + Assessregulatoryintelligencetoassistinthedevelopmentoflocal,regional regulatory strategies + Collectlocal,national,internationalPostMarketSurveillancerequirementsand options for regulatory submission (adverse events) and compliance activities + Identifietheneedfornewpostmarketprocedures,SOPsandparticipatesin development and implementation + Supportthedevelopmentanddeploymentofnewsystemsandprocedureslocally + SupportcontinuousimprovementactivitiesacrossPMSprocessesattheregional level + Supportintegrationofnewacquisitions&PMSprocessesalignment + Liaise withthelocalbusinessinmanufacturingandDesignDivisionstoensure adequate support for the local RAQA and commercial organizations + ProvidesupporttoEMEA/CountryRAQAteamsandincludedactivitiessitting under the franchise lead role when requested + Prepareregularreportsasrequested:weekly/monthlyreports,supportquality management meetings and audits preparation and readiness + Identifytrainingneeds, develop training materials anddelivertrainingatanyorganizationallevel + AssistotherdepartmentsinthedevelopmentofSOPstoensurepostmarket compliance **What you need:** + BS in Engineering, Science, or related degree; or MS in Regulatory Science + Minimum 2 years’ experience + Experience in a highly regulated industry (Medical or Pharma) + Knowledge ofMedicalDeviceDirective (EU/FDA) and Regulations + Fluency in English + Highattentiontodetailandprocessconsciousness + Good communication and analytical skills to engagewithregulatorsandotherkeystakeholdersonroutineand complex matters Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
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