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

Referenz: 409361001900

on 08 July 2020
Stadt
Freiburg
Vertragsart
Festanstellung

The future belongs to those who drive innovation, inspire transformation and fuel collaboration. Our commitment is achieved by working together with our clients in combining the key technologies IT, Engineering and Life Sciences in order to develop innovative solutions for the future. We connect top companies with the sharpest minds in Life Science. All of them united by their burning passion to make use of their talents in order to master the challenges ahead. Are you one of them?

If so, you are what we are looking for as a Team player for a project by one of our customers, a renowned company in the Medical device sector at multiple locations germanwide. Commencing immediately

What you can do for us

  • Prepare and submit applications for conformity assessment/clinical trials of non-active implantable medical devices in the EU and respond to questions from Notified Bodies and Competent Authorities, in a timely and accurate manner
  • Responsible for the compilation and update of CE-dossiers for registrations/clinical trial applications (CTA), advice to concerned development departments regarding the quality, analytical methods, pre-clinical and clinical development to ensure acceptance of the data in EU and assessment of dossiers of third partie
  • Prepare and update product information texts according to company core data and relevant guideline
  • Conduct the maintenance/Life-Cycle Management of the CE mark (preparation and submissions of applications for renewals, change notifications, annual updates etc.) in due time
  • Assess proposed changes by the production centers, marketing departments etc. from a regulatory point of view
  • Coordinate regulatory projects and interact with third parties (e.g. consultants, CROs, distribution partner) concerning regulatory issues
  • Develop regulatory strategies, participate in project teams and act as contact person with regards to regulatory requirements
  • Conduct Due Diligences for established products with regards to regulatory aspects

Please let us know with your application:

  • Your salary expectations, or the range in which your salary should be
  • in which region you are searching (e.g. Biberach, Rhein Main area, Germany etc)

The skills that are needed

  • Natural scientific background (pharmacist, biologist or chemist), approbation, diploma, master’s degree or PhD
  • 2-3 years of experience in EU regulatory affairs for medical devices, combined with profound knowledge of the European regulatory landscape
  • Experience with Medical devices is a plus
  • Self-confident manner combined with strong communication skills – also fluent in Business English, further language skills would be preferable
  • Your skills include strategic and analytical thinking, a highly structured way of working and networking abilities

Why you are in the right place when working with us

We connect the right professionals with the right project, as we do by connecting you with our recruiting projects! Our path together begins with trying to comprehend your ambitions. We shall work together to help you achieve your career objective, by investing in your professional development and mentoring, and by coaching you throughout your career. Modis is a global leader in professional solutions and a dynamic brand with a global focus. We are pursuing ambitious goals in a key market. Our affiliation with Adecco Group opens up a wide array of career choices for you.

You can hardly wait to get to know us? Then a simple click will quickly connect you with us. Just click on "APPLY NOW“ to send us your application.

Your Contact

Herr Santosh Kumar Sandhi

Bewerbung.FreiburgLS@modis.com

Modis GmbH

Life Science

Güterhallenstraße 4

79106 Freiburg

Phone +49 761 3890 8216

www.modis.com

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