Work Flexibility : Hybrid
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
Travel Percentage : 10%
Senior Specialist • Bucharest, Romania