Opslag hos BIOPORTO DIAGNOSTICS A/S

Project Manager Are you ready to make a meaningful impact in the world of healthcare? BioPorto is seeking a talented and driven Project Manager to join our dynamic Research & Development team! About Us At BioPorto, we're on a mission to save lives and enhance patient care with our cutting-edge in vitro diagnostic solutions. As experts in antibodies and assay development, we transform innovative research tools into clinically actionable biomarkers that make a real difference in patient outcomes. Headquartered in Hellerup, Denmark, and listed on the NASDAQ Copenhagen stock exchange, we’re proud to have recently achieved US FDA clearance for our ProNephro AKI (NGAL) test, a critical tool for early detection and management of acute kidney injury. Our Team Join a passionate team of around 45 dedicated professionals globally who embody a roll-up-your- sleeves attitude and an innovative mindset. We are energetic, collaborative, and laser-focused on our goal: to successfully launch our FDA-cleared NGAL test in the US market and improve the quality of life for patients worldwide. At BioPorto, we believe in fostering a supportive and engaging work environment where every team member can thrive and contribute to groundbreaking advancements in healthcare. Your Role We are looking for an enthusiastic colleague to join our team, focusing on project management work for our product development projects, ensuring they are completed on time and within budget. Your primary responsibilities will be to: • Develop and maintain comprehensive project plans and timelines per product development life cycle and design control requirements for multiple projects • • Visualize and effectively communicate interdependencies between different development projects Lead and facilitate communication between functions around scope changes, risks, and competing priorities • • Establish meeting agendas, facilitate team discussions, drive clear and timely team actions and decisions Lead and facilitate communication between functions around scope changes, risks, and competing priorities • • Manage project communication for all stakeholders, including providing leadership updates Maintain company quality standards. Page 2 of 2 Your Qualifications • • • • • • B.Sc. /M.Sc. in biotechnology, biochemistry, or equivalent. PMP or other project management certification Minimum 2 years of experience in project management in the medical device industry Experience with regulatory submissions (FDA, IVDR) is a plus. Familiarity with electronic quality management system (eQMS) Fluent in English (written and oral). As an individual, you are flexible and able to meet timelines while managing multiple activities. You can work independently, ensuring high-quality standards and attention to detail. You enjoy a dynamic working environment where effective teamwork is critical to succeed. Your workplace can either be in the office in Hellerup, Denmark, or you may be located in the US, working remotely from home. No relocation benefits are provided. Our Offer We offer you an exciting and dynamic position, with great opportunities for personal and professional development. You will work in a small and informal team, collaborating with other departments (Production, QA/RA, etc.), where your expertise and opinion will be valued. Additional Information If you have any questions, please contact the SVP of R&D, Ursula Klause ([email protected]; +1 317 306 9450) Please send your application and CV in English using this link: www.bioporto.com/careers 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.