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Your new role A newly created position where you will have an opportunity to shape your role and lead and develop the regulatory affairs team. This rare opportunity could be the next great step in your career. The position is Director Regulatory Affairs to the international MedTech company Cepheid. Located in Solna and you will lead and work in close collaboration with the Regulatory team consisting of three people. Your main responsibility will include leading and developing the Regulatory Affairs team. Moreover, you will for example develop Regulatory Intelligence tools and processes to facilitate product introduction to new markets, provide clear Regulatory input and guidance during new product development and for post-market changes, coordinate WHO qualification program and sustain the business relationship with WHO and supervise Tech File compilation, submission and update for EU regulatory submissions. This position will also require some international travel. What you'll need to succeed You have a Bachelor’s or Master’s degree in Life Science or equivalent, 9-10 years of experience from working with Regulatory Affairs within an IVD or Medical Device industry. In Vitro Diagnostics product experience and molecular diagnostics experience preferred. As a person you are solution and business oriented, communicative and comfortable with standalone decision making. You are a detail oriented person with well-developed organizational and analytical skills. It is important that you thrive in a fast-paced environment with a proven ability to be flexible and adaptable within a changing and dynamic environment. What you need to do nowIn this recruitment, Cepheid is working with Hays. If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV and cover letter in English in the same document. If you have any questions regarding the role, please contact recruitment consultant Isolde Andersson, 070 450 60 26. Your new company Cepheid is a molecular diagnostics leader, committed to improving healthcare with their accurate yet easy-to-use GeneXpert System, and their expanding portfolio of Xpert tests which span healthcare associated infections and other infectious diseases, sexual health, virology and oncology. With more than 20,000 GeneXpert Systems placed globally, Cepheid’s solutions envision a better way for clinical institutions of any size – from reference labs and hospitals to doctors’ offices and remote service providers - to access the full power of molecular diagnostics, enabling the delivery of rapid and accurate test results that can transform patient outcomes while also improving workflow and reducing costs for healthcare providers. As the demand increases for Cepheid’s solutions they are now growing rapidly. We are therefore looking for talented people who share their vision to join the team.
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