Mechanical engineering 
IT & Communications 
Mechatronics 
Automotive engineering 
Aerospace 
Shipbuilding 
Electrical engineering 
Medical technology 
Plant construction 
Projektleiter Regulatory affairs (m/w/d)
Das können Sie bei uns bewegen
- Verantwortlichkeit für die Registrierung der medizintechnischen Produkte sowie die CE-Marktzulassung
- Kommunikation und Zusammenarbeit mit den Behörden und externen Schnittstellen
- enge Zusammenarbeit mit der Entwicklung und den Projektleitern in Projekte
- Sicherstellung der technischen Dokumentation hinsichtlich Normen und Gesetze
- Anpassung der technischen Dokumentation hinsichtlich Rahmenbedingungen
- Verantwortlich für die gesamte CE-Zulassung und deren Prozess
Das macht Sie für uns besonders
- Studium der Medizintechnik oder vergleichbare Qualifikation
- Erfahrung in den regulatorischen Anforderungen in der Medizintechnik
- Kenntnisse in den Richtlinien sowie in der MDR
- Erfahrung mit IDE / PMA Zulassung in den USA
- ausgeprägte Kommunikations- und Teamfähigkeit
- sehr gute Deutsch- und Englischkenntnisse
Please be aware that German is the working language in our project and good German language skills (level B2+) are a prerequisite for this position.
Our benefits
Get the green light for a job that fits your profile and skills. the ideal route for young professionals, our contacts at leading specialist departments will pave the way for you. Show us what you can do and we'll help you succeed!
We stick together – our strong team ethos is a hallmark of ep. Support is provided via supervisors and the ep mentors. Extras include sports, after-work activities, legendary parties, events and the ep portal.
Exciting work, sometimes on multiple projects, in tight-knit teams: the opportunities are manifold! Through ep you can get to know companies from the inside, which means you can learn a new field of work without taking a "detour" on your CV.
Committed work and innovative spirit are in demand at ep: we ensure top performance and valuable ideas for our customers. We also have fun – thanks to optimal working conditions.
Training? Yes please! The ep educational programme with training catalogue and annual credit ensures you can effectively achieve your goals. From external offers to part-time study courses – the possibilities are limitless.
Get up and running towards your personal development goals! These objectives may change as a result of achieved milestones, individual opportunities or a change in your personal situation. Benefit from an abundance of sound prospects.
Do you have any questions?
Questions and answers about the application process at ep can be found in our FAQs.
Contact
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