Regulatory Affairs Specialist/Raporlama Uzmanı İş İlanı
İşveren Hakkında
- İstanbul(Avr.)(Esenyurt)
- Sağlık, Medikal Ürünler
GENEL NİTELİKLER
QUALIFICATIONS AND JOB DESCRIPTION
Qualifications:
· Bachelordegree inEngineeringandTechnicalorHealth/LifeSciencesdepartments ofuniversities.
· Preferably 2to 3yearsexperience inRegulatory Affairs Management in amultinationalenvironment (medical industrywould be anasset).
· Workingknowledge ofregulatoryregistrations inTurkeyorothercountries.
· Workingknowledgeof ISO 13485, MDD (93/42/EEC), FDArequirementsandtheother globalregulations.
· Knowledge in MS Officesoftware (Word, Excel, Powerpoint, Outlook),and SAP isrequired.
· Excellentcommand ofwritten &spoken English ismandatory.
· Teamplayerwithexcellentcommunicationandpresentationskills;abletodevelopcollaborativerelationshipswithvariousstakeholdersbothinternalandexternaltoachieveobjectives.
· Analyticalthinking,resultandsolutionoriented,innovative,proactive,flexibleandstrongability on problemsolving andreporting.Must beabletoidentifycreativeoptionsforresolvingissuesthatrespondto multiplestakeholderinterestsandneeds,
· Strongplanning,followup,reporting,coordinationandorganizationskillstoachieveaccurateand timelyresults.
· Nomilitaryobligationformalecandidates.
· Beconfident,positive, self-motivated& abletoworkindependently
· Be agoodteamplayer
· Goodcommunicationskills
· Teamworkoriented,abilitytoestablishandmaintaineffectiveworkingrelationships\willingnesstolearn
JobDescription:
· Implement andsupportregistrationand re-registrationtaskswiththeauthorities.
· Supporttheestablishmentanddevelopment ofthe RAsystem.
· Responsibleforcoordinationandimplementation of RAactivities inlinewithinternationalregulations,Set Medikalpoliciesandprocedures.
· Ensurethecompletion ofregulatory certification/registration/notification/listingactivitiesin acorrectand timelymanner.
· Evaluatetheeffects ofchangecontrolactivitiesfromregulatoryperspectiveandimplementrequiredregulatory steps on atimelymanner.
· Followthecurrencyanddelivery ofqualitydocumentsandrecordstothethirdpartiesduringregistrationactivities.
· Follow-up ofdevelopmentsandchanges inthelocal &internationalregulatorypolicyrules,legislationsandguidelineswithimpacttoSet Medikalactivities.Analyzeavailableregulatoryandcomplianceinformation.
· Update ofdomestic (ProductTrackingSystem)andinternationalproductregistrations,tokeeptrack oftheup-to-dateness oftheregisteredproducts,tofulfilltheneccessaryupdates on time.
· Tofollowtheactuality oftherepresentativesandcertificatesregistered inthe ÜTSsystemand, incase ofrevision,tocontacttherelevantmanufacturersanduploadthenewcertificatestothesystem in atimelymanner.
· CommunicatingwiththeMinistryandotherofficialinstitutions,respondingtolettersfromtheseinstitutionsincludingsubsequentrecordingandarchivingactivities
· Toperformandfollow-upEudamedrecordentries
