Regulatory Affairs Manager | Chemiker (m/w/d)
Raguse Gesellschaft für medizinische Produkte mbH
Job Summary
As a Regulatory Affairs Manager at Raguse Group, you will be responsible for ensuring the regulatory compliance of Class I, Is, IIa, and IIb medical devices in accordance with EU Regulation 2017/745 (MDR). Your daily activities will include creating and maintaining technical documentation, managing product data in the EUDAMED database, and overseeing product registrations. You will play a pivotal role in optimizing regulatory processes and integrating them with the existing ISO 13485 quality management system. The role involves close collaboration with internal departments, notified bodies, and suppliers, as well as supporting internal and external audits. This position is particularly attractive due to its high level of responsibility in a future-proof medical technology industry, offering flexible working hours, home office options, and a family-like medium-sized company environment with flat hierarchies and direct access to senior management.
Required Skills
Education
Completed vocational training or university degree, preferably in a technical, scientific, or medical field with a focus on Regulatory Affairs or Quality Management.
Experience
- Initial professional experience in Regulatory Affairs or Quality Management specifically for medical devices
- Experience in creating and maintaining technical documentation according to MDR standards
- Practical experience in managing communication with notified bodies and external stakeholders
- Experience in planning and supporting audits
Languages
Additional
- Willingness to travel for audit purposes is required. Candidates must be able to serve as a deputy for the Quality Management Representative (QMB) or the Person Responsible for Regulatory Compliance (PRRC).