その他、技術・専門職系(メディカル)
RA Specialist/Manager
その他、技術・専門職系(メディカル)

RA Specialist/Manager
の転職・求人情報はすでに掲載終了しております。(掲載期間12月21日~1月19日)

※ 掲載時の募集要項はページ下部よりご確認いただけます。
他の方はこんな求人もチェックしています
ミドルの転職では、各専門分野のコンサルタント4723が紹介する181019の転職情報を掲載しています。
希望条件で探す
職種、勤務地、年収などを組み合わせて探すことができます。
掲載時の募集要項掲載期間:2022/12/21 ~ 2023/01/19)
その他、技術・専門職系(メディカル)

RA Specialist/Manager

外資系企業 海外展開あり(日系グローバル企業) 大手企業 管理職・マネジャー マネジメント業務なし 海外折衝 土日祝休み

募集要項

募集背景
<About the Position>

The focus is to complete and maintain regulatory approvals and clearances of assigned products.
仕事内容
<About the Position>
The focus is to complete and maintain 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
* 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
* 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

Real is part of the larger SThree K.K group

To find out more about Real, please visit www.realstaffing.com | Real についてもっと詳しく知りたい方はこちらへ→ www.realstaffing.com



Award winner of:

Great Place to Work 2019 | Growth Company of the Year by TALint Recruitment Awards 2019 | Best Healthcare & Life Sciences Recruitment Company of the Year by Recruitment International Awards 2018
応募資格
必須
The focus is to complete and maintain regulatory approvals and clearances of assigned products
歓迎
<Preferred Experience>
・Experience in preparing domestic and international product submissions
・Master's Degree or equivalent in related field(e.g. Pharmaceuticals)
フィットする人物像
<Education and Experience>

* Bachelor's Degree or equivalent in in related field or scientific discipline (e.g. Biology, Microbiology, Chemistry),
* 5 years RA(Class3 and/or 4 product) experience of previous related experience Required

<Preferred Experience>

* Experience in preparing domestic and international product submissions
* Master's Degree or equivalent in related field(e.g. Pharmaceuticals)

<Additional Skills>

* Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
* Excellent written and verbal communication skills including negotiating and relationship management skills
* Good ability to read and write English
* Full knowledge and understanding of Japan regulations relevant to medical devices(regulation requirements for new products, product changes, and new product development systems), Class 3 and/or Class IV devices
* Good leadership skills
* 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
* Native level Japanese
雇用形態
Permanent
勤務地
Tokyo
年収・給与
JPY9,000,000.00 - JPY12,000,000.00 per annum + competitive

会社概要

社名
非公開
事業内容・会社の特長
<About the Company>

The global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company put helping patients into its life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, the company focuses on helping patients regain and improve the quality of their life.
30代、40代の転職サイトはミドルの転職に会員登録すると…
  • 1あなたの希望にマッチした「新着求人情報」が届きます。
  • 2仕事が忙しくても、コンサルタントからの「スカウト」を待てます。
  • 3気になるリスト」などの便利な機能を使えるようになります。
転職先がご決定されたみなさまへ
毎月50名様にAmazonギフト券5,000円分をブレゼント!
転職先情報の入力へ
Q.
エージェント(人材紹介会社)を利用して、転職をするメリットは何でしょうか。
A.
一般に公募していない非公開求人情報が得られるほか、キャリアやスキルを査定して最適な転職先を紹介してもらえる、転職を希望する企業がある場合、採用の可能性を判断してもらえます。

実際の転職活動の際にも、紹介先企業の企業の人事方針や経営に関する詳細な情報が事前に得られたり、履歴書や職務経歴書の書き方や、面接でのアドバイスがもらえるなど、有利に転職活動ができるようにサポートをしてもらえます。

また、より良い待遇条件で転職が決まるように条件面での交渉をしてもらえます。
RA Specialist/Managerの転職・求人情報 17126394。プロのコンサルタントがサポートする日本最大級のキャリア転職情報サイト。年収800万円以上の高年収、管理職、スペシャリストの求人、非公開求人スカウトも多数。