Beschreibung
Technical Writer - Medical Devices - Germany
A German speaker is not essential but of course, desirable. Also, this role might be able to be performed in a part time capacity.
Essential Skills/Experience
Teamwork - essential
Communication - essential
Engineering/Science qualification with 3 years of working within R&D/QA/RA in a medical device environment.
Technical writing experience within a medical device environment - essential
Attention to detail and accuracy - essential
Ability to work well under deadlines and pressure
The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.
German language skills
ISO13485
Behaviours/Values
Flexible and adaptable.
Able to work on own initiative and as a team player.
Good organisational skills
Job Purpose
Create and manage technical documentation in line with the Medical Devices regulatory requirements.
Key Responsibilities
Key responsibilities will include (but are not limited to) the following:
Generation and maintenance of Technical Files for medical devices
Use technical writing skills to clearly describe technical information
Understand standards and their application to medical devices
Planning, protocol generation, testing and report generation for medical devices
Ensuring that records produced are filed in accordance with relevant procedures.
Key Relationships/Interfaces
Operations
R&D
QA/RA