Your responsibilities

• 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.
• 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.

Our requirements

• Hold a Bachelor's Degree in relevant fields such as Life Sciences, Pharmacy, Biomedical Engineering, or a related discipline.
• Have a minimum of 1-2 years of experience in Regulatory Affairs, preferably within the medical device or in vitro diagnostics industry.
• 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.