Regulatory Affairs Manager (m/f/d) Medical Devices (20635553)

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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:

* 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
Bewerben über hokify
+49 711 72240 198


ARBEITSORTE

Karte anzeigen
* 60308 Frankfurt am Main

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