1. 転職サイト ビズリーチ
  2.  > 求人検索
  3.  > Bilingual regulatory lead - medical devices

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)

Bilingual regulatory lead - medical devices

年収:800万 ~ 1200万

ヘッドハンター案件

部署・役職名 Bilingual regulatory lead - medical devices
職種
業種
勤務地
仕事内容 Roles and Responsibilities:



Manage/coordinate the project from onsite

Communicate with customer for MDR transition project

Proposal and SOW review

Identification of applicable regulatory standards and requirements for said Medical devices

Classification of Medical Devices as per country specific regulations like USFDA, TPD, MDD/MDR, PAL and other National/Regional regulations

Identification of ‘Substantially Equivalent’ devices with proper justification

Interpretation of standards’ requirement statements and assist Project team to derive design requirement statements

Identification of applicable safety and compliance tests

Preparation and compilation of Technical documents for regulatory submission

Support Project teams for DHF and DMR preparations

Compile Technical File /Regulatory Dossier for Regulatory submission

Participate in review meetings and customer calls, as required by project team

Creating awareness to Design Engineers on Medical Device Regulations, through facilitation, conducting training programs

Support QAD for QMS process improvement activities and during internal/external audits

応募資格

【歓迎(WANT)】

Skills:

Knowledge on Part 820, Part 11, ISO 13485, MDD, MDR, IEC 60601x, IEC 62304, ISO 14971, GxP, GHTF Guidelines

Previous experience within a regulatory environment, and knowledge of active medical devices

Experienced in preparing and submitting Technical files to Regulatory Agencies and/or Notified Bodies

Working experience in Medical Device manufacturing company

Good interpersonal skills and communication skill

Ability to work in a timeline driven environment

Lead Auditor, RAPS certification would be an added advantages

Speak fluent English and Japanese

Read/Write in English and Japanese

Educational Qualification: B.E./B.Tech (Bio-Medical, Electrical, Electronics, Mechanical.)

Total working experience: 10-15 Yrs

Relevant experience: 8+ Yrs

更新日 2018/08/14
求人番号 784879

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
パスワード ※ 半角英数字記号10文字以上20文字以下で入力してください パスワードの安全度:
現在の年収
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