Regulatory Affairs Specialist

Regulatory Affairs Specialist

Edwards Lifesciences

Prague, Czech Republic

Role Purpose:

Support of Edwards Regulatory Affairs activities in the EU and EEMEA market to ensure the compliance of Edwards manufactured and/or distributed products with the applicable regulatory requirements of the region.

Major Job Functions:

  • Keep current with local regulations related to the distribution of medical devices;
  • Submit requests for clinical trial authorization and monitoring their progress, report of SAE;
  • Maintaining licenses current by resubmitting at appropriate intervals;
  • Communicating promptly national requirements to European RA functions and local management;
  • Establishment of licenses and permits for all products codes before distribution for EMEA region;
  • Local management of field corrective actions;
  • Provide Technical information to Bids and Tenders department for the region;
  • Interact with regulatory agencies;
  • Participate in the control of the code release to ensure compliance with EMEA regulations.

Required Education/Skills:

  • Bachelor’s degree required – preferably in Natural Sciences: Biology, Pharmacy, Medicine and/or Chemistry;
  • Strong analytical and communication skills essential;
  • Detail-oriented, rigorous, and work well with other internal functional groups;
  • Solid understanding of EU and/or EEMEA regulatory requirements & procedures with minimum 3 years experience;
  • Ability to work in a multicultural environment;
  • Computer skills in Microsoft windows environment (including Word, Excel, PowerPoint) required;
  • Fluent in English, other languages are a plus.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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