Freelancer - technical documentation - Germany
- 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
- 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
- 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)