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Job Details

Specialist, Quality Compliance

Type

Full time

Location
Japan-Tokyo HQ
Job reference

Req-37653

Posted for

6 days ago

エドワーズライフサイエンスは、構造的心疾患の領域において、患者さんを中心にした医療イノベーションの世界的リーダーです。世界100カ国以上で数百万人の患者さんに医療技術を提供し、治療アウトカムの向上や、医療的アンメットニーズに対する持続的なソリューションを創出することに全力を注いでいます。

■職務内容

医療機器（TAVI：経カテーテル大動脈弁置換術）の安全性情報に関する安全管理業務全般

・国内/Globalのデータベースへの情報入力（英語/日本語）：安全性情報の英訳、GVP業務

・行政報告書の電子申請業務：Web による申請業務

・医療現場担当者（営業他）への各種問い合わせ

・GVP業務に関するGlobalの関係部門との調整

・行政、業界、学会等への安全性に関する対応

・各種報告書、データ作成

■応募要件

PCスキル（Word, Excel, PowerPoint, Outlook, Teams, etc.）

心臓構造疾患治療デバイスの立合い経験3年以上

英語文献の読解ができる方（目安：TOEIC 700以上）

仕事の正確な方

革新的医療機器の安全性を牽引してゆく責任感のある方

・歓迎要件

新しいことに挑戦してゆくのが好きな方

循環器または心臓関連製品・疾患の知識がある方

医療機器に関する経験がある方

海外と英会話でのコミュニケーションの取れる方

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Job reference

Req-37653

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Type

Full time

Location
Japan-Tokyo HQ
Posted for

6 days ago

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About Edwards Lifesciences

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.

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What we offer

Diversity Inclusion and belonging
Diversity Inclusion and belonging
Diversity Inclusion and belonging

Diversity, inclusion & belonging

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Team members at campus park
Team members at campus park

Our benefits

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For United States Applicants Only:

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Know your Rights: Workplace Discrimination is Illegal Poster

Family and Medical Leave Act (FMLA)

Employee Polygraph Protection Act (EPPA)

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Important Notices for Candidates

Important Notices for Candidates

COVID Vaccination Requirement Notice

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

For US Applicants Only

Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers, the California Fair Chance Act, and any other applicable regulation.

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