法規資深專員

我要應徵
  • R48515E41

  • 臺北市

  • 中高階

  • 醫療器材設備

  • 生物醫藥科技

  • 1. Ensuring company complies with all QMS and product-related regulations.
    2. Keeping up with international medical device legislation, guidelines and customer practices in all countries that the company is exporting to.
    3. Preparing submissions of QMS and product licenses and renewals to strict deadlines.
    4. Monitoring and setting timelines for QMS and product licenses and renewal approvals.
    5. Undertaking and managing regulatory inspections.
    6. Liaising with, and making presentation to regulatory authorities.
    7. Specifying labelling, packaging and storage requirements.
    8. Reviewing labels and packages before product is released.
    9. Partner with engineers on device license approvals.
    10. Connect with manufacturing on process and labelling.
    11. Work with sales & marketing on product position and marketing claims.
    12. Reviewing company practices and providing advice on changes to QMS.
    13. Co-work with marketing & RTs for Post-production activities.
    14. Must :
    A. Understand EU MDR 2017/745 and familiar with Directive 93/42/EEC
    B. Understand MEDDEV 2.12/1 rev 8 and additional guidance
    C. Familiar with FDA 510k submission and product listing
    D. Familiar with Medical device risk management requirements

  • NTD / 面議 (經常性薪資達4萬元或以上)

  • 依法令規定之相關福利 / 勞工退休金提撥 / 勞、健保

  • 1. RA work experience 5yr + in medical device field.
    2. Critical thinking
    3. Writing skills
    4. Communication
    5. Organization
    6. Time management
    7. Interpersonal skills
    8. Valid car driver's license
    9. Language requirement : Bilingual in Mandarin and English ( must )
    10. be able to travel between Taipei and I-Lan.

  • 英語(很流利)

  • 大學以上

  • 不需負擔管理責任

  • 周休二日

  • 1人

  • 2021 / 04 / 16


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