市販後調査/安全管理 - 医療機器メーカー

お問合せ Kyoko Kubota
JOB ID JO-2203-469285

☑Foreign business
☑English language required
☑Japanese language required
☑Flex time

[Position]
市販後調査/安全管理

[Company Description]
外資系医療機器メーカー

  • 脳神経外科、神経救命診療、整形外科、脊椎治療などの分野に製品を提供しています
  • 製品は革新的な技術で競合優位性を誇ります
  • 風通しの良い職場環境、ワークライフバランス、今後の製品ポートフォリオが充実している会社です

[Responsibilities]
GVP Tasks and Product Complaint Handling

  • Execute GVP tasks regulated in GVP requirements including Fuguai reporting/ Field actions
  • Execute product complaint handling. (Create complaint investigation letter for customers, Communicate and negotiate with Global team)
  • Communicate with Sales rep/ Marketing personnel with regards to product complaint
  • Create and revise Package Insert (J-IFU) including negotiation with PMDA/ MHLW
  • Execute product risk assessment
  • Correspondence with Japan authorities (PMDA, Notified body and TMG) with regards to audit
  • Execute internal audit

[Requirements]

  • Minimum level of education needed to perform duties
  • Minimum 5 year GVP experience in Medical Device (preferred Class IV) Industries
  • Excellent verbal and written communication skills
  • Ability to multiple tasks, prioritize and work under pressure
  • Negotiation skills with Japan authorities (MHLW, PMDA, TMG, Notified body)
  • Good organization skills and ability
  • Computer skills - MS-Word, Excel, PowerPoint

[Language Requirement]

  • English Language level: Business level
  • Japanese Language level: Fluent - Native Level (Equivalent to JLPT N1)
  • Work permission in Japan required

[Work Hours]
9:00〜17:40
フレックス制有 コアタイム11:00〜15:00

[Salary]
7〜9 million JPY
※Experiences and skills will be considered

Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.

Reference: JO-2203-469285
Seniority Level: Mid-Senior level
Job Function: Health Care Provider, Quality Assurance