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- Preparation and submission of applications for new marketing authorisations/ registrations and of responses to questions in a timely and accurate manner
- Compilation and update of dossiers for marketing authorisations/ registrations, advice to concerned development departments regarding the quality, anayltical methods, pre- clinical and clinical development to ensure acceptance of the data worldwide. Assessment of dossiers of third parties
- Appropriate preparation and conduct of scientific advice meetings with regulatory authorities, communication with regulatory authorities worldwide
- Maintenance/ Life- Cycle Management worldwide (preparation and submissions of applications for renewals, variations, submissions, annual reports etc. in due time)
- Coordination of change control procedures (collection of regulatory assessments worldwide) and their international implementation
- Coordination of regulatory projects, communication with third parties (e.g. consultants, CROs, distribution partner) concerning regulatory issues, management of regulatory consultants
Regulatory Affairs Manager - Frankfurt am Main, Deutschland - Da Vinci Engineering GmbH
Beschreibung
STELLENBESCHREIBUNG
Nothing provides more motivation than success. Da Vinci Engineering is highly committed to ensuring the own employees' success. Become a part of us
Regulatory Affairs Manager (m/f/d) Medical Devices
Stellen-ID: 20317
Standort:
Frankfurt am Main
We are searching for intelligent and innovative employees for our Automotive customers as Mercedes-Benz, Porsche and Robert Bosch.
If you are interested in working for a dynamic company with flat hierarchy, we look forward to receiving your application.
Your tasks: