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QRC, Regulatory Affairs Specialist

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Date: Jan 1, 2022

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. We provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Our portfolio combines well-known product brands such as Maquet, Pulsion, Atrium, Lancer and Datascope – just to name a few.

A career at Getinge will provide career opportunities that both inspire and challenge. Here, you can make a difference every day.

 

 

Job Purpose:

As a specialist in the regulatory affairs department, you will help achieve business goals in Japan by obtaining regulatory approvals for your products to ensure that product introduction plans in Japan are met without delay.

Understand the Pharmaceutical Affairs Law and other requirements and contribute to the maintenance of regulatory approval for the assigned products.
 

Functions:

  • Under the guidance of the supervisor, perform the following
  • Obtain permits and approvals for assigned products in accordance with Japanese laws and regulations.
  • Comply with Japanese laws and regulations.
  • Prepares documents for new or revised business licenses.
  • Evaluate product changes and respond to regulatory filings, etc. as necessary.
  • Carry out work in accordance with departmental policies
  • Provide support to other team members to ensure smooth operations
     

Key duties and responsibilities:

  • Under the guidance of the supervisor, collaborate with the manufacturer and other related departments to carry out tasks such as product introduction
  • Obtains or supports the obtaining of permits and approvals for assigned products. In the process of obtaining permits and approvals, may need support in making general policy decisions and developing strategies, but will generally carry out the entire process on his/her own and obtain permits and approvals.
  • Respond to or support changes in assigned products or business locations
  • Develop good working relationships with government authorities
  • Work as part of a team and contribute to the team's goals
     

Quality System Duties and Responsibilities:

Follow and adhere to internal Quality System processes for the area of responsibility of the Regulatory Affairs Department
 

Knowledge/Skills/Experience:

  • Bachelor's degree from a four-year university (or junior college)
  • Experience in pharmaceutical affairs, quality, development, etc. in the pharmaceutical or medical device industry (Class III or higher)
  • More than 5 years of experience in regulatory affairs application
  • English proficiency (able to respond to emails and carry out daily conversation) 
  • Ability to understand and implement regulatory strategy
  • Communication skills and negotiation skills
  • PC skills (Microsoft Word, Excel, Power Point)
     

Personal qualities:

  • Proactive behavioral skills
  • Ability to make proposals
     

Internal and External Contacts:

Main contacts, internal:

  • Global RA
  • BA
  • Q&S
  • Business Unit Marketing

 

Main contacts, external:

  • Pharmaceuticals and Medical Devices Agency
  • Ministry of Health, Labour and Welfare
  • Industry Associations
     

Special Features/Conditions:

  • Travel to Japan to participate in academic conferences, etc. (less than 5% of annual working days on average)
  • Overseas travel for discussions with overseas manufacturers, etc. (less than 5% of annual working days on average)
     

 

We look forward to receiving your application. 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. We hope you will join us on our journey to become the world’s most desired medtech company.

 

 

Treatment:

  • Full-flexible (prescribed daily working hours: 7 hours and 30 minutes)
  • Standard working hours: 9:00am - 5:30pm (1 hour break)
  • Salary: Monthly salary + Deemed overtime allowance (30 hours per month)
  • Bonus: Once a year
  • Benefits: Social Insurance, Defined Contribution Pension Plan (401K), Benefit One (Cafeteria Plan)
  • Trial period: 3 months

 

Getinge Core Value: Getinge の企業文化

Employee introduction: Meet our Employees (getinge.com)

Showroom Introduction:【 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)