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Leader/Manager-Regulatory

年収:800万 ~ 1200万

ヘッドハンター案件

部署・役職名 Leader/Manager-Regulatory
職種
業種
勤務地
仕事内容 Job Description: The Regulatory Leader/Manager as subject matter expert work along with the project team to ensure Regulatory compliance and bring best practice.
Roles and Responsibilities:
• Identification of applicable regulatory standards and requirements for said Medical devices
• 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
• Support for Compiling Technical File /Regulatory Dossier for Regulatory submission
• Participate in review meetings and customer calls, as required by project team
• Support QAD for QMS process improvement activities and during internal/external audits
応募資格

【歓迎(WANT)】

Require Skills:
• Previous experience within a Japanese regulatory environment, and knowledge of active medical devices
• Experienced in preparing and submitting Technical files to Regulatory Agencies and/or Notified Bodies
• Good interpersonal skills
• Ability to work in a timeline driven environment
• Consulting experience
• Cooperate with foreign company/team member

Optional Skills:
• Previous experience within a FDA.MDR/MDD/IVDR regulatory environment, and knowledge of active medical devices Lead Auditor, RAPS certification would be an added advantages
• Speak fluent English and Japanese
• Read/Write in English and Japanese
• Knowledge on Part 820, Part 11, ISO 13485, MDD, MDR, IEC 60601x, IEC 62304, ISO 14971, GxP, GHTF Guidelines

Total working experience: 10-15 Yrs

更新日 2017/12/08
求人番号 630242

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