Regulatory Affairs Specialist Medical Device Budapest Hungary

Our partner market leading IVD 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 renewals
• Maintaining efficient communication between manufacturing sites and local affiliates / distributing partners
• Providing regulatory support for products prior to launch
• Ensuring successful information flow regarding local regulatory requirements and expectations
• Tracking status of submissions pending at regulatory agencies as required.
• Participating in regulatory agency inspections
• Implementing department improvement projects as needed

Key requirements are:

• University degree in the field of Life Sciences or equivalent
• Full working proficiency in English
• 12 years of Regulatory experience in any industry preferably LS or MD
• Analytical problem solving and critical thinking skills.
• Excellent communication and networking skills
• Prior 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