Senior RA specialist - 医療機器メーカー

勤務地 東京都
雇用形態 正社員
給与 ¥9000000.00 - ¥12000000.00 (年収)
専門 ライフサイエンス(医療機器・製薬・化学・ヘルスケア・農業・畜産),
職種 薬事,
お問合せ Yuuki Umezawa
JOB ID JO-2203-468992
about Yuuki Umezawa

☑外資系企業
☑英語力が必要
☑リモートワーク可能
☑フレックス勤務

[ポジション]
Senior RA specialist

[事業内容・会社の特徴]
外資系医療機器メーカー

  • 心臓に関する製品を手掛けており、そのほとんどがシェアトップクラス
  • 社員の在籍年数は約13年と中長期的に就業ができる環境、20〜30年以上の就業者も多数
  • 医療業界全体の内で確固たる技術力・ブランド・領域トップクラスのシェアを誇る製品群を持ち、革新的な医療機器を開発していることからForbes The World's Most Innovative Companies TOP 100 の常連企業

[仕事内容]

  • Prepare and oversee documentation packages for submission to Japan regulatory agencies. Track timelines and documents milestone achievements for inclusion in regulatory submissions. May interact with regulatory agencies as part of submission review and on-site audit support. (e.g., IDE's, PDMA, PMA's, annual reports, 510(k)'s, STED's and CE marking design dossiers and technical files)
  • Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues; also keeps management apprised of alternative actions. Review and approve protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy.
  • Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing regulatory strategic plans to teams for solutions
  • Monitor proposed and current global regulations and guidance; assess impact of such regulations and guidance on assigned project(s), propose suggestions on utilizing regulatory updates to expedite approval process
  • Review promotional material and labeling content product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy
  • Other incidental duties

[応募資格]

  • Bachelor's Degree or equivalent in related field , 5 years RA(Class3 and/or 4 product)
  • Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry)
  • Experience in preparing domestic and international product submissions

[歓迎されるスキル・経験]

  • Master's Degree or equivalent in (e.g. Pharmaceuticals)

[語学力]

  • 英語力:ビジネスレベル以上
  • Japanese Language level: Fluent - Native (Equivalent to JLPT N1)
  • Work permission in Japan required

[給与]
900〜1200万円
※能力・経験を考慮し当社規定により決定します

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Reference: JO-2203-468992
#LI-REMOTE
Seniority Level: Mid-Senior level
Job Function: Health Care Provider