Quality and Regulatory Manager - 617939

Quality and Regulatory Manager

Regulatory, quality

募集職種

人材紹介会社
インテリジェンス・グローバル・サーチ
採用企業名
非公開  
求人ID
617939  
会社の種類
外資系企業  
勤務形態
正社員  
勤務地
東京都 23区
給与
700万円 ~ 900万円
勤務時間
会社規定に準ずる
更新日
2016年11月16日 14:01

応募必要条件

職務経験
3年以上  
キャリアレベル
中途経験者レベル  
英語レベル
流暢  
日本語レベル
ネイティブ  
最終学歴
大学卒: 学士号  
現在のビザ
日本での就労許可が必要です  

募集要項

Client Overview:

Leading Healthcare medical company focusing on surgical innovation, pharmaceuticals and disposable products.

Responsibilities:

  • Lead and prepare medical device submissions to PMDA and 3rd party review organizations, i.e. BSI for a range of Class 1, 2 & 3 medical products including medical consumable, hardware and a range of globally regulated cardiology and endovascular products.
  • Coordinate and compile regulatory preparation and maintenance of Certificates of Foreign Government and required legalization activities.
  • Facilitate negotiations with the Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labour, and Welfare (MHLW).
  • Lead and/or participate in project team meetings as a regulatory representative providing solutions and regulatory strategies as they relate to product registrations.
  • Serves as liaison with PMDA and MHLW during the submission process, collaborating on regulatory strategy, testing plans, and responding to requests for additional information.
  • Provide regulatory assessment and guidance and respond to inquiries regarding product submissions to cross-functional team, including regulatory, marketing, and engineering, on device, manufacturing process and supplier changes
  • Maintain a well-organized and efficient filing system of regulatory records
  • Maintain information in various compliance databases and produce reports, as needed
  • Initiate, review and approve Documents Change Order requests, CAPAs, Nonconformances, etc.
  • Ensure compliance with regulations and guidelines as well as company SOP’s and protocols

スキル・資格

  • College level degree in related discipline, preferably in Science field. Advanced degree preferred.
  • 3+ years related experience in medical device industry. 5 years is a plus.
  • Direct regulatory experience/involvement with PMDA and local authorities
  • Experience with Class I, II are essential and class III preferred.
  • Excellent understanding of the Japanese and international medical device laws and regulations, i.e. PMDL, ISO 13485
  • Prior experience as a project leader with strong project management skills.
  • Excellent communication skills demonstrated through technical writing experience is a must.
  • The main language for day to day work will be conducted in Japanese. However, overseas communication via email and phone with US based offices is in English. Business level English (written and oral) is a requirement in order to professionally carry out your job roles.

会社概要

インテリジェンス・グローバル・サーチは、日本に拠点を置く人材紹介会社であり、株式会社インテリジェンス・グループに所属しています。私たちは、多国籍企業であるお客様に対し、多言語に対応可能なプロフェッショナル人材の紹介サービスを以下の領域において提供しております。

  • 会計
  • 銀行および金融
  • 人事
  • 販売およびマーケティング
  • サポートおよびアドミニストレーション
  • 情報技術

インテリジェンス・グローバル・サーチは、インテリジェンス・グループのグローバル人材に特化した人材紹介部門です。インテリジェンス・グループは現在、アジア全域に4,700人を超えるスタッフを擁していて、2万社を超える企業と業務提携を結んでおり、日本で第2位の規模の人材紹介会社です。私たちは、数十年に及ぶ取引関係とネットワーク構築を利用して、採用企業様と候補者様に最適な人材紹介サービスをご提供することを目指しています。

Intelligence Global Search is the international recruitment arm of the Intelligence group. The group currently employs over 4,700 staff throughout Asia and has partnerships with over 20,000 companies making it the second largest permanent placement agency in Japan. We aim to leverage decades of business relationships and networking so as to provide clients and candidates with an unrivaled recruitment service.

We specialize in placing multilingual professionals into multinational firms within the following areas:

  • Accountancy
  • Banking & Finance
  • Engineering
  • Executive Management
  • Human Resources
  • Life Sciences
  • Sales & Marketing
  • Support & Administration
  • Supply Chain
  • Technology

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