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QcRM, Post Marketing Surveillance Manager

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Date: Nov 30, 2022

Location: Tokyo, JP

Company: Getinge

 

 

At Getinge we have the passion to perform

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers – and to save more lives.

Are you looking for an inspiring career? You just found it.

 

Job Purpose:

  • Safety Manager under the Pharmaceuticals and Medical Devices Act
  • Comply with and implement GVP requirements for medical and non-medical devices under Japanese domestic laws and regulations
  • Compliance and operation of quality requirements based on global quality management system and regulatory requirements
     

Functions:

  • Perform safety management operations under the Pharmaceuticals and Medical Devices Act
  • Collecting and reviewing complaints and safety management information (matters related to quality, efficacy and safety, and other information necessary for the proper use of medical devices) after product shipment, and implementing necessary measures based on the results
  • Coordinates with relevant internal departments and government officials (PMDA, TMG, MHLW) in implementing safety assurance measures
  • Manage, modify, and maintain procedures for the collection and review of complaints and safety management information and the processes necessary to implement safety assurance measures

 

Key duties and responsibilities:

  • PMS Group Manager (management and training of subordinates)
  • Safety Manager
  • Administrative reporting and related response to failure reports, foreign action reports, and provision of safety information
  • Determination of whether or not an administrative report is required, MDR determination, and preparation of records thereof
  • New/revised attachments
  • Operations related to recalls/fixes
  • Risk management
  • Perform other duties as assigned by the superior
     

Knowledge/Skills/Experience:

  • Four-year university degree (science)
  • Expertise and experience in medical device safety management (minimum 3 years required)
  • Management experience (minimum 3 years required)
  • English language skills and experience to communicate well globally (TOEIC 800+, conference calls can be facilitated)
  • Expertise and experience with ISO 13485:2016 and ISO 14971:2019
     

Personal qualities:

  • Strong team management skills
  • Proficiency with Japanese regulations and ISO 13485:2016 standards
  • Presentation skills, including training
  • Proactive, energetic, self-directed and professional, with the ability to build good interpersonal relationships with other departments
  • Practical experience in the field of technology and leadership
  • High level of understanding of assigned duties and ability to continuously complete tasks on time
  • Excellent relationship building, influencing and negotiation skills
  • High IT literacy with working knowledge of Microsoft products (Word, Excel, PowerPoint, etc.)
     

Internal and External Contacts:

Main contacts, internal:

  • All employees

Main contacts, external:

  • Suppliers
  • Notified Body
  • Ministry of Health, Labor and Welfare
  • Clients

 

About us 

Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future. We are committed to diversity, equity and inclusion and to sustainability with a goal to be CO2 neutral by 2025. We believe in giving our employees the flexibility they need and make every effort to foster a learning culture that supports their personal development and creativity. Our passionate people hold our brand promise ‘Passion for Life’ close to heart. 

If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world’s most respected and trusted medtech company.