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

RA Specialist
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27日~1月25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:2022/12/27 ~ 2023/01/25)
その他、技術・専門職系(メディカル)

RA Specialist

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

募集要項

募集背景
<About this Role>

This role's primary mission is to accelerate products' approval for Japanese Market by working as project's member. Depends on the person's skill, experience and motivation, the position might lead the project. The primary mission includes work based on required knowledge on Japanese regulation including Clinical affairs and Quality management area that are necessary for product submission. Also, the person might work with external experts for Pre-approval clinical trial for regulatory or PMS purpose when necessary.
仕事内容
RA Specialist
<Main Responsibilities>

* Contribute to establishing and maintaining effective project management system to accelerate product approval.
* Develop effective regulatory strategy for each project and achieve active product introduction.
* Enhance internal compliance and risk management system based on understanding of the Japanese PMD Act and other business-related laws and regulations.
* Prepare and submit approval, certification, and the notification of medical device applications/Maintain registrations (license of Foreign Manufacturer registration, business license)
* Support in license renewal projects
* Maintain and develop relationships with regional colleagues, business partners, industry associates, regional regulatory bodies, and medical society.

* Motivated to learn other areas that are related to RA such as reimbursement or Clinical work. The person will be requested to learn about these areas according to company situation and discussion to set personal development goal.

* Enough knowledge about QMS for RA product submission, QMS inspection and reliability inspection. (Minimum requirement)
* Motivated to lean about QMS to establish/improve Quality Management System.

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
To accelerate products' approval for Japanese Market by working as project's member.
歓迎
*Willingness to manage long-term project or team project, and to challenge on complicated situation/subjects.
*Experience in establishing/improving Quality Management System (can be partially).
*Bachler degree of science (pharmacy, engineering, and others)
*Business level English in verbal communication
フィットする人物像
<Qualifications>

<Minimum>

* Bachelor's Degree
* 5 years or more experience in RA working with Medical Device in Japan (product registration for class III or IV preferred)
* Knowledge on Japanese Pharmaceutical and Medical Device Law/Regulation and product submission process
* Native level Japanese proficiency
* Business level English (writing and reading)
* Smooth operation of MS Word, PowerPoint, Excel, and Visio (+Photoshop, preferred)
* Overseas business trips (0-2/year) and domestic business trips (0-10/year)

<Preferred>

* Willingness to manage long-term project or team project, and to challenge on complicated situation/subjects.
* Experience in establishing/improving Quality Management System (can be partially).
* Bachler degree of science (pharmacy, engineering, and others)
* Business level English in verbal communication
雇用形態
Permanent
勤務地
Tokyo
年収・給与
JPY7,000,000.00 - JPY9,000,000.00 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 implantable hearing medical device and solutions that helps people of all ages to lead full and active lives.
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
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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の転職・求人情報 17468838。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。