NEW

RA/QA Specialist

■職務内容 Products registration for new products of IVD and medical device Maintenance of approvals c…

求人会社名:非公開

メンバー
600万円~1000万円

募集要項

  • こだわり条件

    設立50年以上 語学(英語)を生かす 年間休日120日以上

  • 仕事内容

    ■職務内容

    Products registration for new products of IVD and medical device
    Maintenance of approvals certifications and registrations (Periodical renewal and Change control)
    Audits/inspections yearly surveillance QMS compliance inspection applications and QMS conformity to control manage and review.
    Documentation preparation for regulatory package inserts product labeling regulatory training standards regulation tracking and translations.
    Role as “品責” of medical device
    Post marketed activities including complaint evaluation medical device reporting vigilance reporting product correction removals and recalls.

    Regulatory Affairs
    ・ Prepare and submit applications measure inquires and obtain approvals for new products on schedule
    ・ Assess change information and prepare and submit applications measure inquires and obtain approvals for partial changes and amendments
    ・ Prepare and submit notifications of existing products
    ・ Register renew and maintain business licenses for foreign manufacturer licenses
    ・ Renew and maintain business licenses in local
    ・ Collect review and track standards regulations and all applicable requirements
    ・ Prepare QMS compliance investigation application and obtain QMS conformity certificates for manufacturing facilities to be subjected
    ・ Prepare applications obtain and maintain reimbursement points
    ・ Control preparation and revision of regulatory documents including package inserts
    and labels ・ Review promotional materials and customer information from RA point of view
    ・ Work for disclosure of regulatory document
    ・ Support to make import document

    Quality Assurance
    ・ Make and revise documentation of Quality Management System
    ・ Work for the improvement and maintenance of Quality Management System
    ・ Work for internal audit and external audit
    ・ Work for QC test as receiving inspection of product
    ・ Report quality and safety information including filed corrective actions/recall to authorities
    ・ Work for processing complaint handling…

  • 職種分類

    医療・介護・福祉系専門職 > 医療・介護・福祉系専門職 > その他(医療・介護・福祉系専門職)

  • 業種分類

    医療・ヘルスケア・介護機器

  • 応募条件

    Skills Capabilities:
    ・Strong written and verbal communication skills in Japanese
    ・Self motivated and result oriented
    ・Integrity and respect for peoples
    ・Strong willingness to comply with regulations and procedures
    ・Attention to detail

    Min Knowledge Experience required for the position:
    ・ Education: Bachelor’s degree in a science or related field
    ・ Experience:
    (1)Fulfill requirement for “Hinseki” of medical device. It is over 3 years experience in Quality Assurance for medical device or fulfill requirement for “Anseki” of medical device (IVD). A person who has the ability to carry out safety management work properly and smoothly. (IVD) (mandatory) (医療機器製造販売業における国内品質業務運営責任者の資格要件又は医療機器(体外診断用医薬品)安全管理責任者の資格要件は必須)
    (2)Over 2 years experience in Regulatory Affair in IVD/medical device or pharmaceutical environment (mandatory)

    Additional Skills/Knowledge:
    ・Language: Business level of English skill is preferable (Read instructions write e mails are essential)
    ・Knowledge of QMS and PMD Act.
    ・Computer skills required: Word Excel PowerPoint PDF

  • 年収

    600万円~1000万円
    600万円 - 1000万円

  • ポジション

    メンバー

  • 雇用形態

    正社員

  • 勤務地

    東京都

  • 勤務時間

    09:00 ~ 18:00

  • 休日・休暇

    【有給休暇】20
    有給休暇 初年度 20 日 ( 入社月により按分 )
    完全週休二日制 年末年始
    【有給休暇】有給休暇は毎年20日付与されます

  • 福利厚生

    【通勤手当】全額支給
    【社会保険】健康保険
    厚生年金
    雇用保険
    労災保険

求人会社情報

  • 事業概要

    求人紹介時にご案内致します。

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    ■職務内容 Products registration for new products of IVD and medical device Maintenance of approvals c…

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