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Quality Regulatory Compliance, Post Marketing Surveillance Specialist

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Date: Aug 24, 2021

Location: Tokyo, JP

Company: Getinge


Together we can make a difference

At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. A career at Getinge provides career opportunities that both inspire and challenge. Here, you can make a difference every day.



【Job Purpose】

  • Ensure compliance with quality business requirements of Japanese regulations for medical devices and non-medical devices 
  • Provide support to the Safety Manager in accordance with the Pharmaceutical and Medical Devices Act 
  • Conformance and operation of quality requirements based on local and global quality management systems and regulatory requirements 
  • Compliance with global quality management system requirements




  • Execute safety management operations under the Pharmaceutical and Medical Devices Act. 
  • Collect and review post-shipment complaints and safety management information (matters related to quality, efficacy and safety, and other information necessary for the proper use of medical devices), and implement necessary measures based on the results. 
  • In the implementation of safety assurance measures, the Company shall coordinate with relevant internal and administrative personnel. 
  • Develop, confirm, and maintain processes, procedures, and management methods necessary for the collection and review of complaints and safety management information and the implementation of safety assurance measures. 
  • Collect, review, analyze and report on complaint and safety management information in order to maintain processes, procedures and controls. 


【Key duties And responsibilities】

  • Execute safety management operations under the Pharmaceutical and Medical Devices Act. 
  • Support the Safety Management Officer 
  • Administrative reporting on defect reports, foreign measures reports, and provision of safety information, and related response work 
  • Determination of whether or not an administrative report is required, MDR determination, and preparation of records for these. 
  • New issuance and revision of attached documents 
  • Work related to recall/refurbishment 
  • Risk management duties 
  • Execution of other duties as instructed by superiors 


【Qualification requirements】

  • Four-year university graduate (or junior college graduate) 
  • Expertise and experience in medical device safety management (about 3 years) 
  • English skills and experience for good communication with global (reading and writing TOEIC 600-, conversation (at the level of meetings, etc.)) 
  • Expertise and experience as an internal auditor for ISO 13485:2016 
  • Expertise and experience with ISO 14971:2019 


【Personal qualities】

  • Familiarity with Japanese regulations and ISO 13485:2016 standards 
  • Presentation skills, including training 
  • Proactive, energetic, self-directed, professional, and able to build good interpersonal relationships with other departments 
  • Work experience in technical and leadership areas 
  • High level of understanding of assigned duties and ability to complete work on time on an ongoing basis 
  • Strong relationship building, influencing and negotiation skills 
  • Computer literate with a working knowledge of Microsoft products (Word, Excel, PowerPoint, etc.) 



Full Flexible Time (Prescribed working hours per day is 7 hours 30 minutes, Standard working hours 9:00 to 17:30 / 1 hour break)

Salary: Monthly salary + deemed overtime pay (30 hours per month)

Bonus: Once a year

Benefits: Social insurance, defined contribution pension system (401K) Benefit One Cafeteria Plan

Probation Period: 3 months


【Company Information

Getinge Core Value: Getinge の企業文化

Employees Introduction Page: Meet our Employees (getinge.com)

Showroom Introduction: http://【 ゲティンゲ エクスペリエンスセンター東京 360°ツアー 】 (getinge.com)