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

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

ARBEITSORTE

Karte anzeigen

• 60308 Frankfurt am Main