Save Job Back to Search Job Description Summary Similar JobsA global renown medical device company specializing in class I-IV productsTake lead in RA submissions and product maintenance for regulatory approvalAbout Our ClientGlobal medical device company specializing in class I-IV productsFocusing in cardiovascular, respirator, intensive care, etc. for various unmet medical needsRich development pipeline to deliver progressive/innovative productsGlobal culture with extensive collaboration with stakeholdersHybrid working styleJob DescriptionRegister and develop regulatory strategies for product approvalLead in any change notification product changes from a regulatory point of viewCommunicate with PMDA and other health authority discussionsCollect information related to product changes and share it internally, evaluate the impact, document, manage records, and handle pharmaceutical affairs.Work in accordance with department policies and procedures related to your own work. Prepare for audits and respond to auditors. Participate in industry activities.The Successful ApplicantUniversity degree in scientific or related fieldRA experience in the global medical device industryRA submission experience for class I-II products (class III-IV preferred)High fluency in English and Japanese (Non-native level speakers will not be selected)Ability to communicate/negotiate with local health authorities (PMDA, MHLW, etc.)What's on OfferCompetitive salaries and benefitsGreat work life balanceWork with industry leaders who are solving various unmet medical needsAmazing career progressionInternational working environmentContactZach ItozuQuote job refJN-012025-6648235Phone number+813 6832 8683Job summaryFunctionLife SciencesSpecialisationMedical DevicesSpecialisationHealthcare / PharmaceuticalLocationTokyo 23 WardsJob TypePermanentConsultant nameZach ItozuConsultant phone+813 6832 8683Job ReferenceJN-012025-6648235Company TypeForeign Multinational
