Post Market Surveillance Senior Specialist

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%