The company has established a leading position in the fields of orthopaedics and ophthalmology. The German branch is responsible for the certification of medical products as well as their distribution in Germany and the Benelux countries. In the coming years, the innovative company plans to introduce significant new developments.
What are your responsibilities as a " Specialist Regulatory Affairs (m/f/x)"?
Preparation of registration dossiers for non-European approvals for parent company
Assistance in creating and maintaining MDR-compliant technical documentation for medical devices
Processing and implementation of design changes
Creation of packaging materials for medical devices, pharmaceuticals, and dietary supplements. This includes coordination with the design agency, contract manufacturers, printers
Research and evaluation of new regulations in the medical device sector and implementation in the technical documentation
Compilation of batch documentation for market release
What requirements should you bring as a " Specialist Regulatory Affairs (m/f/x)"?
Completed degree in natural sciences, medicine, engineering, or technology, or equivalent qualifications.
At least two years of professional experience in the international registration of medical devices (Class I to III)
Expertise in medical and scientific fields
Successfully completed studies in a scientific discipline
Ability to review, interpret, and evaluate medical and scientific data and publications
Capability to accurately and formally present and formulate scientific results and findings in both English and German
Experience in creating technical documentation in STED format, ideally under MDR requirements
Proficient in German and English, both spoken and written
What does the company offer you?
Contract type: Permanent full-time contract.
Vacation: 30 days/year
Home office: Up to 40% remote/mobile.
Working hours: 40 hours/week.
Access: On-site parking and excellent public transportation connections.
A dynamic work environment with a flat organizational structure
Opportunities to quickly take on responsibility and make a meaningful impact
Are you interested in this position? Then you should apply now! If you desire additional or alternative job opportunities, I also welcome your application. I look forward to receiving your application!
Karrierestufe
Berufseinstieg
Beschäftigungsverhältnis
Vollzeit
Tätigkeitsbereich
Gesundheitswesen, Produktmanagement und Wissenschaft und Bildung
Branchen
Herstellung medizinischer Geräte und Arzneimittelherstellung
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