Device Project Coordinator | Device Project Coordinator (m/w/d)
Office Events P & B GmbH
Job Summary
This role involves coordinating device development projects within an internationally operating industrial company, focusing heavily on regulatory compliance and technical documentation. The Device Project Coordinator will be responsible for creating and maintaining project-relevant documents within the Design Control process, adhering to regulatory requirements (specifically 21 CFR 820.30) and internal guidelines, primarily in English. Day-to-day tasks include taking over work packages from the Device Team Leader, providing technical consultation on processes and tools, and contributing to 'Device Project Management Excellence' initiatives to implement new development processes. The ideal candidate holds a Master's degree in engineering or natural sciences, or a Bachelor's degree coupled with significant professional experience in developing medical or combination products, possessing expert knowledge in Design Control, GMP, and Change Control processes. Fluency in English and good German skills are required, along with basic project management knowledge and a structured, highly proactive work style.
Required Skills
Education
Master's degree in Engineering or Natural Sciences, or Bachelor's degree with several years of professional experience in the field of medical/combination product development
Experience
- Professional experience in the development of medical or combination products
- Expert knowledge as a Device Project Coordinator in the development of medical and combination products
- Experience in the Design Control process
- Experience in technical development projects (ideally)
Languages
Additional
- Employment is limited to 24 months with the option for extension and permanent takeover; Option for remote work up to 3 days per week.
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