Regulatory Affairs Specialist Medical Device Budapest, Hungary

6 days ago

Budapest, Budapest, Hungary Carbyne Full time €40,000 - €60,000 per year

Our partner,  global pharmaceutical company, is looking for its newest member to join their EMEA focused  Regulatory Affairs Team in Budapest. This new specialist role will be focusing on preparation, organisation, and tracking of regulatory submissions in the EMEA region, while also performing regulatory surveys to assure the product compliance.

Key responsibilities are:

Assembling international regulatory submissions of product introduction and renewalsMaintaining efficient communication between manufacturing sites and local affiliates / distributing partnersProviding regulatory support for products prior to launch  Ensuring successful information flow regarding local regulatory requirements and expectationsTracking status of submissions pending at regulatory agencies as required.   Participating in regulatory agency inspectionsImplementing department improvement projects as needed

Key requirements are:

University degree in the field of Life Sciences or equivalentFull working proficiency in English1-2 years of Regulatory experience in any industry, preferably LS or MDAnalytical, problem solving, and critical thinking skills.  Excellent communication and networking skillsPrior experience with SAP is preferred.  

Should you be interested in the details of this vacancy feel free to leave a comment with your details or submit your CV for this role

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