About the Company
We are seeking a dynamic and detail-oriented Quality and Regulatory Affairs Manager (Medical Devices) to join our team and contribute to our ongoing success.
About the Role
You can look forward to these tasks:
* Evaluation, selection and continuous monitoring of suppliers in accordance with internal and external requirements.
* Planning and conducting supplier audits (international and national audits) to ensure quality standards and regulatory requirements.
* Development of measures for supplier qualification and further development in coordination with purchasing and production.
* Creation and maintenance of supplier evaluations and monitoring of supplier performance.
* Support in the preparation and implementation of QM audits to ensure compliance with regulatory requirements.
Responsibilities
We look forward to receiving your application if you have this profile:
* Completed studies in engineering or comparable training (technician), quality management, medical technology
* Very good knowledge in the area of Regulatory Affairs (RA) and ideally practical experience in dealing with medical devices and the corresponding regulatory requirements (e.g. MDR, FDA)
* High quality awareness
* Very good MS Office and ERP knowledge, ideally Majesty
* Very good written and spoken German and English skills
* Teamwork and communication skills
* Structured and reliable way of working
* Fluent in English and German B2