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Freelancer - technical documentation - Germany  

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Posted on : 08 May 2017

Project Description

Job profile
  • Preparation of development, quality and regulatory documents in compliance with regulatory standards, e.g. MDD, CFR 820.
  • Duration: 6-8 months, potentially longer. (The project will be limited to 6-8 months, but can be extended depending on the customers resource situation.)
  • Start: As soon as possible

Your profile
  • Minimum 3-4 years of experience in medical device documentation
  • Fluent English (all documents and all project communication is in English)
  • Driver's license
  • EU citizen

Job description
  • Within ongoing development and life cycle management projects support is needed for the establishment and update of DHF and DMR documentation including: requirements engineering, change management, design verification / re-verification, design validation, process validation, transport validation, design transfer, etc.
  • You will be working in an existing project as a team member reporting to the responsible project leader within an established ISO 13485 quality system.
  • The work shall be done on customer site and in home office (depending on the project situation)