Are you looking for a role where precision and knowledge directly impact the success of global products?
Join the team in a key operational support role, expertly handling Regulatory Affairs documentation for the EMEA market.
If you are passionate about ensuring product label information is perfectly compliant with dynamically changing European and national legislation, then this opportunity is for you.
what we offer- EMEA region process support
- Efficient recruitment process
- Hybrid working model
- Flexible working hours
- Private medical care
- Life/accident insurance (PZU)
- Sports card (for you or your loved ones)
- Online cafeteria – benefit platform
- Fulfilling global registration requests and creating other internal documents to support the registration process
- Performing a review of promotional materials to ensure compliance with the EU MDR and local regulations
- Directly managing notifications/registrations/submissions/communication to Competent Authorities.
- Interfacing with Regulatory Affairs consultants
- Supporting internal and external clients regarding regulatory documentation and managing the SharePoint platform
- Processing payments for the department and managing vendor contracts using SAP or SharePoint, ensuring all updates are correctly reflected in the Client's system
- Approximately 3 years of experience in a Regulatory Operations role at an international medical device company
- Practical experience reviewing promotional materials for medical devices
- Direct experience reviewing and approving labels
- Experience in meeting the requirements of the EU Medical Device Regulation (MDR)
- Understanding of the change control process for medical devices
- Excellent project management skills and experience
- SAP experience
- Higher education (Bachelor's degree or higher)
Employment agency entry number 47
this job offer is intended for people over 18 years of age
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