Technical Documentation Specialist

Salary/Rate:€50,000 - €55,000
Job type:Perm
Town/City:Kaltenkirchen
Country:Germany
Business Sectors:Regulatory Affairs
Job ref:25024
Post Date:15. 03. 2024
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About the Role

Technical Documentation Specialist

Passionate about making a difference in the medical technology industry? 

Do you love working with technical documentation, in regulatory affairs or quality management?


We want to hear from you!

Overview:

My client is a leading manufacturer and supplier of high quality ENT treatment units and diagnostic devices for hospitals and private practices, with active customer contacts in over 40 countries.


Tasks:
  • Create, update, and maintain Technical Documentation for medical devices following MDR guidelines
  • Contribute to the design, development, and implementation of new products from a regulatory perspective
  • Conduct regulatory reviews of existing products and assist service providers with product changes
  • Perform tests on various devices to ensure compliance and approval
Your Profile:
  • Degree in medical technology, regulatory affairs, or related field
  • Familiarity with relevant standards such as MDR, ISO 60601-1, ISO 14971
  • Experience in creating and maintaining Technical Documentation for medical devices
  • Background in developing medical devices
  • Proficiency in CAD software (e.g. SolidWorks)
  • Good knowledge of MS Office suite
  • Fluent in both spoken and written German and English (B2+ level)
  • Result-oriented team player with the ability to work independently and proactively

Interested? 
Please apply with your CV or contact Vivien Zsuzsanna Urban for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management.

vivien.urban@adaptivelifescience.com
+49 30 16639819

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