Technical Documentation Specialist

Are you a professional in the medical technology field, looking for a new challenge?

 

Are you well-versed in the preparation of technical documentation and ensuring compliance?

 

Would you be interested in joining a leading company who are known for their innovation and quality?

 

We're currently supporting a client in the medical device industry who are headquartered in Tuttlingen and are looking to strengthen their team.

 

Key Responsibilities:

• Develop and manage technical documentation for Class I-IIb medical devices.
• Engage in the certification process and assist in the audit of technical documentation.
• Collaborate regularly with the R&D and Quality Management teams.
• Oversee verification and validation activities with external vendors.
• Identify relevant standards and keep abreast of changes in legal requirements for medical devices, ensuring compliance.
• Carry out additional duties as specified by the MDR.

 

Requirements:

• A degree in Biomedical Engineering, Life Sciences, or a related discipline.
• At least 3-5 years of proven experience in preparing technical files for medical devices in accordance with MDR.
• Comprehensive understanding of MDR requirements and associated guidelines.
• Strong attention to detail with the ability to work autonomously, manage priorities, and meet deadlines.
• Fluency in German and English.

 

If you're interested in this position, please apply and/or contact Hollie Dear at Adaptive Life Science for more information.