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Regulatory Affairs Manager - Japan (m/w/x)


Regulatory Affairs Manager - Japan (m/w/x)


  • Responsibility for registration projects for non-active medical devices in ophthalmology. A big focus of your tasks will be the Japanese market.
  • Prepare registration projects for non-active medical devices in the field of ophthalmology by analysing re-quirements from international regulations that are relevant for approval, examining and evaluating im-plementation options with relevant stakeholders and independently deriving approval strategies
  • Planning, managing and controlling complex registration projects; implementing concepts and planned actions and ensuring approval
  • Participate in international projects for new registrations, registration of product changes or changed re-quirements triggered by changes in regulations
  • Participate in development projects and change committees on approval-relevant issues and specify nor-mative and regulatory requirements
  • Continuously analyse and optimise RA processes working together with, e.g. Quality Management, Glob-al Regulatory Affairs, Clinical Affairs, in order to improve procedures or adapt them to new regulations
  • Work in an international team of Regulatory Affairs Managers who, together with Branding, Business Management and Logistics, ensure the market availability of our products

You Profile

  • University degree in a technical, economic, business or comparable field
  • Knowledge of the regulations for medical devices with a focus on Japan and related international standards
  • experience in the field of regulatory affairs, in medical technology or comparable
  • Knowledge of the regulations for medical devices with a focus on Japan and related international standards
  • An analytical, systematic and goal-oriented approach
  • Experience in project management
  • Team spirit and good communication skills
  • Experience in solving complex tasks in a matrix organization
  • C2 Level Japanese and Business fluent in English
  • Posted Today
  • Full time
  • JR_1006258

About Us

  • Step out of your comfort zone, excel and redefine the limits of what is possible. That’s just what our employees are doing every single day - in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people.In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the Carl Zeiss Foundation: to bring science and society into the future together.Join us today. Inspire people tomorrow.Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.Apply now! It takes less than 10 minutes.

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Regulatory Affairs Manager - Japan (m/w/x)

Premium company ZEISS Gruppe

Veröffentlicht am 16.06.2022

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