Clinomic is a dynamic, fast-growing MedTech startup developing innovative technological solutions for critically ill patients. We were founded in 2019 as a spin-off of RWTH Aachen. We offer a positive collaborative work environment in an interdisciplinary and international team with flat hierarchies and many attractive perks.
We are looking for a Senior Quality and Regulatory Affairs Manager to help maintain our Quality Management System and manage the conformity assessment process for our medical devices.
Your responsibilities
- Technical and disciplinary management of the QM/RA team and reporting directly to the management.
- Creation, checking and maintaining the technical documentation of our products.
- Development of an QM/RA strategy.
- Coordination, implementation, and maintenance of national and international product approvals.
- Communication with authorities, internal specialist departments, external service providers and international customers.
- Implementation and continuous improvement of the established processes and promoting our quality culture at Clinomic.
About you
- Completed technical or scientific degree or a comparable qualification.
- Several years of professional experience in a similar position
- In-depth knowledge of the usual approval requirements and standards of medical technology, (e.g., B. ISO 13485, ISO 14971, 21 CFR part 820, MPG, MDR)
- Excellent project management, and leadership skills. Ability to provide leadership to the RA/QM team.
- Superior communication skills and experience handling interdisciplinary cooperation and technical project development.
- You love being organized and developing timelines, are skilled at holding others accountable, and know how to escalate project-related issues in a timely manner.
- A high level of teamwork and communication skills.
- Excellent writing, oral presentation and communication skills in English and German.
Bonus points, if ...
- You have experience with agile project management.
- You have knowledge of the regulations of other markets.
- You have a background in computer science.
Benefits
- Competitive salary, commensurate with experience.
- Support in personal development and reaching your career goals in a flat hierarchy surrounding.
- Modern working environment with trusted working hours.
- Dual career program for partner hiring.
- International and diverse work environment (Our working language is English).
At Clinomic, we know that diversity inspires innovation and creativity, and we welcome people from all backgrounds and experiences.
Sounds great?
Send us your CV with your start date and salary expectations.
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