Edwards Lifesciences Regulatory Affairs Specialist in Prague, Czech Republic
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
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
Maintain appropriate positive contacts with regulatory government officials to enable the clear understanding of requirements and defense of Edwards’ positions when appropriate.
Close monitoring of the dynamic regulatory environment in selected areas of the EU / EMEA region.
Prompt communication of regulatory changes to appropriate functions within the organization.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.