Regulatory Affairs Manager (m/f/d) Medical Devices
Da Vinci Engineering GmbH
- 60308 Frankfurt am Main
- Vollzeit
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STELLENBESCHREIBUNG
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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:
- 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
Your profile:
- Natural scientific or medical device engineering background (pharmacist, biologist, chemist, etc.) approbation, diploma, master degree or PhD
- Approx. 3 -6 years of experience in international regulatory affairs field for medical devices
- Experience in registration of high risk devices (class III)
- Experience in medical device registration in other countries
- Fluent in English, further foreign languages prefered
- Microsoft Office skills
- Networking abilities with internal and external partners
You can expect ...
- Experience in exciting and international projects
- Continuous salary development
- Da Vinci Corporate Benefits
- On-the-job training and language courses
- Appreciation, motivation and commitment
Kontaktdaten für Stellenanzeige
Frau Andrea Cindric
Da Vinci Engineering GmbH
Hauptstätter Straße 149
70178 Stuttgart
+49 711 72240 107
apply.job.20635553@hokifyjob.com
+49 711 72240 198
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Job-ID.: 20635553
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