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RA Officer

Location: Tokyo, Japan Salary: competitive
Sector: Regulatory Affairs (RA) Type: Permanent

Global medical device organisation and one of the world's leading suppliers of products into segments including casting, bandaging, wound management and compression garments.

A number of the company medical's well-known brands are among the most trusted names in the Japanese healthcare profession. This can be attributed to our longevity in the market but also due to our continuous product improvement mindset and drive to introduce the latest technologies and state-of-the-art materials.

The company committed to developing customer confidence, trust and loyalty, by offering high-quality products and services and striving to repeatedly deliver on our commitments.

  • Establish and maintain status of Market Authorization Holder status
  • Coordinate product registration activities required to enable and maintain supply of company products in Japan.
  • Overview/advise on Japan regulatory developments and issues to ensure ongoing compliance of company's products/services. Keep Senior Management informed of regulatory status of products and significant regulatory issues.
  • Monitor and advise Tokyo management team on specific Japanese legislation affecting Company's products and services.
  • Maintain product-related licenses and permits required under Japanese legislation.
  • Ownership/facilitation of Product Introduction & Change Process.
  • Ownership/facilitation of Customer Complaints Process.
  • Provide guidance to Management team on packaging and labelling compliance requirements.
  • Specific documentation responsibilities.
  • Maintain and make available product-related safety information, and investigate/report on product adverse incidents.
  • Post-market regulatory activities.
  • Corporate & External Activities.
  • Support of Quality System.

  • Well balanced between meticulousness and efficiency
  • Keen learner and researcher to keep up to date with new regulations
  • Skilled at leading and cooperating with internal and external stakeholders
  • Flexible mindset to work around possible issues
  • Excel at following through with multiple projects simultaneously

To find out more about Real Staffing, please visit www.apac.realstaffing.com

Real Staffingについてもっと詳しく知りたい方はこちらへ→ www.apac.realstaffing.com/ja