1. 転職サイト ビズリーチ
  2.  > 
  3. 求人検索
  4.  > Sr Spec/Mgr
  5.  >  Regulatory Affairs

転職・求人情報の詳細をご覧になる場合は会員登録(無料) が必要です

新規会員登録(無料)

Sr Spec/Mgr, Regulatory Affairs

年収:1000万 ~ 1400万

ヘッドハンター案件

部署・役職名 Sr Spec/Mgr, Regulatory Affairs
職種
業種
勤務地
仕事内容 Completes and maintains regulatory approvals and clearances of assigned products.

【Key Responsibilities】
・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
労働条件 【勤務時間】
9:00~17:30

【休日】
完全週休2日制(土・日)、祝日、年末年始

【その他休暇】
有給休暇:初年度10日(但し、入社月により比例付与)、年間最高20日間付与
その他:病気、介護等の場合の特別休暇取得制度有

【福利厚生】
社会保険:健康保険(東京薬業健康保険組合)、厚生年金保険、雇用保険、労災保険

【その他福利厚生】
保険加入:総合福祉団体定期保険(死亡及び高度障害)、所得補償保険(就業障害時)
財産形成:従業員持株制度、財形貯蓄制度(ともに会社からの補助あり)
各種慶弔金:結婚、出産、子女の小学校入学、本人・家族慶弔金
その他:退職金制度、団体扱いの生命保険、提携福利厚生施設、リロクラブ
応募資格

【必須(MUST)】

【Education and Experience】
Bachelor's Degree or equivalent in in related field , 5 years RA(Class3 and/or 4 product) experience of previous related experience Required and
Bachelor's Degree or equivalent in in scientific discipline (e.g., Biology, Microbiology, Chemistry)Experience in preparing domestic and international product submissions Preferred or
Master's Degree or equivalent in (e.g. Pharmaceuticals) Preferred
転職回数が少ない方


【Additional Skills】
・Coursework, seminars, and/or other formal government and/or trade association training required
・Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
・Excellent written and verbal communication skills including negotiating and relationship management skills
・Excellent problem-solving, organizational, analytical and critical thinking skills
・Good ability to read and write English
・Full knowledge and understanding of Japan regulations relevant to medical devices, Class Ⅲ and/or Class IV devices
・Full knowledge and understanding of Japan regulatory requirements for new products or product changes.
・Full knowledge of new product development systems
・Good leadership skills and ability to influence change
・Strict attention to detail
・Ability to interact professionally with all organizational levels
・Ability to manage competing priorities in a fast paced environment
・Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
・Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
・Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

受動喫煙対策

屋内禁煙

更新日 2022/04/21
求人番号 2162106

採用企業情報

この求人の取り扱い担当者

この求人に含まれるキーワード

転職・求人情報の詳細をご覧になる場合は会員登録(無料) が必要です

メールアドレス ※ メールアドレスは公開されません
新規会員登録(無料)

新規会員登録(無料)ボタンをクリックすると個人情報の取り扱い、及び、利用規約に同意したものと見なされます

転職が決まりご報告いただいた方にはお祝いを用意しております。

ページ先頭へ