Device Project Coordinator | Device Project Coordinator | M/W/D - Referenz 001048
consult16 GmbH
Job Summary
This role involves coordinating device projects for an internationally successful pharmaceutical company, focusing heavily on regulatory compliance and technical documentation within the Design Control process. The coordinator will be responsible for creating and maintaining project-relevant documents in English, ensuring adherence to regulatory requirements (like 21 CFR 820.30) and internal guidelines. Key tasks include supporting the Device Team Lead in project organization, documentation, and providing technical advice on processes, methods, and tools. The ideal candidate possesses a Master's degree in Engineering or Natural Sciences, or a Bachelor's with extensive experience in medical/combination product development. Expertise in Design Control, GMP, and Change Control processes is essential. This is an attractive opportunity to contribute to 'Device Project Management Excellence' and work within an international, interdisciplinary team environment, initially offered as a 24-month fixed-term contract near Mainz, Germany.
Required Skills
Education
Master's degree in Engineering or Natural Sciences, or Bachelor's degree with several years of professional experience in medical/combination product development
Experience
- Professional experience in the development of medical or combination products, or experience in the Design Control process (required for Bachelor degree holders)
- Expert knowledge in the development of medical and combination products
- Basic experience in Project Management, ideally in technical development projects
Languages
Additional
- Initial 24-month fixed-term contract; Work location is near Mainz, Germany; Hybrid work model (up to 3 days remote after onboarding); Must comply with regulatory requirements (e.g., Design Control according to 21 CFR 820.30)
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