Regulatory Affairs Business Partner (m/f)

The Regulatory Affairs Business Partner is responsible for creating, submitting, and maintaining product notifications in CEE countries, tracking regulations, updating relevant systems and trackers, and supporting the Regulatory Affairs team as needed. Job Description: - Create, submit, and maintain product notifications. - Review and approve documents to ensure accuracy, completeness, and compliance with regulations. - Maintain metrics related to product releases, ensuring timely compliance with regulatory requirements. - Track regulations applicable to medical devices and in vitro diagnostics, monitoring both EU and local requirements. - Review advertising and promotional materials to ensure compliance with local and corporate requirements. - Ensure close collaboration with distributors and local business teams to support market expansion across the CEE region - Support marketing, sales, and tenders by providing technical support and addressing regulatory questions. - Input and maintain accurate data, including licenses and registration records, in internal regulatory databases. - Report product complaints according to corporate and regional requirements.

- Hold a Bachelor's Degree in relevant fields such as Life Sciences, Pharmacy, Biomedical Engineering, or a related discipline. - A minimum of 3–5 years of experience in Regulatory Affairs within the medical device industry is required; experience in the pharmaceutical industry is considered an advantage. - Possess exceptional verbal and written communication skills for effective interaction with competent authorities, trade associations, and internal teams. - Demonstrate the ability to work effectively with diverse teams. - Exhibit strong analytical skills to track, interpret, and apply regulatory changes and their impact on product compliance. - Show high accuracy and thoroughness in reviewing and approving documents, ensuring compliance with regulations.