Student Worker, Regulatory Affairs Are you a motivated student looking to gain practical experience in Regulatory Affairs within the vitro diagnostics (IVD) industry? Do you have an interest in medical devices, science, quality, and regulatory compliance? If so, we would like to hear from you. BioPorto Diagnostics is seeking a Student Worker in Regulatory Affairs to support our growing Regulatory Affairs team. This position offers a unique opportunity to gain hands-on experience with international regulatory requirements, technical documentation, and clinical activities supporting innovative diagnostic products. As a Student Worker in Regulatory Affairs, you will support regulatory and clinical activities for IVD devices and work closely with a team of experienced regulatory professionals. You will collaborate cross-functionally with colleagues across the organization and gain valuable insight into the regulatory lifecycle of medical devices. Key responsibilities · Support continuous optimization and standardization of regulatory processes and procedures. · Support preparation and maintenance of technical documentation and regulatory dossiers. · Assist with international product registrations and regulatory renewals. · Maintain regulatory documentation, records, and databases. · Conduct regulatory intelligence activities and monitor changes in global regulatory requirements. · Support various regulatory and clinical projects as needed. Your qualifications · Currently enrolled in a Bachelor’s or Master’s degree program in Engineering, Pharmacy, Life Sciences, Biotechnology, Biomedical Sciences, or related discipline. · Interest in Regulatory Affairs, medical devices, diagnostics, or healthcare. · Previous Regulatory Affairs experience is an advantage but not required. · Strong written and verbal communication skills in English. · Detail-oriented, structured, and able to work independently. · Able to manage multiple tasks and deadlines in a dynamic environment. · Strong analytical and organizational skills. About BioPorto Diagnostics BioPorto Diagnostics is an international in vitro diagnostics company focused on improving patient outcomes through early and accurate detection of acute kidney injury and other critical conditions. We are committed to innovation, quality, and regulatory excellence in bringing life-saving diagnostics to patients worldwide. Our People We foster an energetic and dynamic work environment characterized by team spirit, commitment, humor, and an informal social culture. We have a can-do attitude, where we help each other achieve our common goals, and have successfully obtained FDA clearance of our NGAL test for the US market. If you wish to be part of our organization, we would like to hear from you. Our Offer We offer a unique opportunity to gain practical experience in Regulatory Affairs, exposure to IVD regulations, and mentoring from experienced professionals. You will become part of a supportive and collaborative working environment with flexible working hours adapted to your studies and valuable experience within a publicly listed diagnostics company developing innovative healthcare solutions. Additional Information If you have any questions regarding the position, please contact, Monika Bak, [email protected] , Senior Director, Regulatory Affairs, BioPorto Diagnostics A/S. Please send your application and CV in English using the Jobindex Quick Apply function. LINK Your application will be treated with confidentiality. Interviews will be performed in parallel to the application period. We reserve the right to proceed with the employment process if the right candidate is identified during this period. BioPorto provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.