Clinical Affairs Specialist · CellaVision' s Headquarters · Hybrid Remote

CellaVision works to advance laboratory workflow and diagnostic certainty through intelligent microscopy. We are a world leader in digital microscopy and offer a full solution including instruments and reagents. Our products are used in health care services around the globe.Interested in joining CellaVision as a Clinical Affairs Specialist and be part of our journey to deliver new high-quality products to the market? Now you have the chance! At CellaVision and in the Clinical Affairs team you will work in an international environment with a friendly and collaborative atmosphere and with exciting challenges almost every day!How you will contributeAs a Clinical Affairs Specialist, you are responsible for planning and executing performance evaluations, during pre- and post-market studies for CellaVision’s products. The clinical performance evaluations generate large amounts of complex data which you will analyze and draw conclusions from. You will also take an active part in interacting with internal experts product development projects and external laboratories. You will report to Director Quality, Clinical and Regulatory Affairs.As a Clinical Affairs Specialist you will for example:Design clinical performance study plans.Collect, label, and keep track of samples to be used for internal and external performance testing.Plan, initiate, and coordinate clinical performance studies that are in compliance with applicable regulations and company procedures.Process data from clinical performance studies, including, but not limited to analysis, interpretation, and compiling of reports.Contribute to and review submissions to authorities.Interact with all departments at CellaVision as well as directly with external investigators.What you will bringYou will bring a positive and constructive attitude towards work. To be successful in this role we believe you have strong analytical skills as well as an eye for details when it comes to analyzing data and drawing conclusions from it. You need to be structured and able to plan, organize and prioritize your own work effectively. We believe that you are self-driven, full of initiative, and take responsibility for your work. Since you will have a broad network internally and externally, you also need to be a team player with a well-developed communicative ability, who thrives in a social context.We believe that you have a university education equivalent to a Master of Science degree or similar within the life science area.You have a minimum of 3 years of experience in clinical studies related to medical devices, preferably IVD, or experience of working in a controlled laboratory environment, e.g. as a biomedical analyst at a hospital laboratory.You have an understanding of legal and regulatory requirements and standards for in vitro diagnostics (e.g., ISO 13485, IVDR and QSR 21 CFR 820).You have an advanced level of English, written and verbal.It’s an advantage if you also have experience in statistics and knowledge of ISO standards related to clinical performance, such as ISO 20916, ISO 14155 and CLSI guidelines.It is also a bonus if you have experience in cell morphology, such as e.g. WBC differentials.What we offerCellaVision has a world-leading position in digital cell morphology and we see our employees as our primary resource for our ongoing innovation and success. Joining CellaVision means that you will surround yourself with over 100 employees that are both passionate and ambitious. We believe that an open and friendly company culture along with employees that take initiative and responsibility is what makes us grow together. We have created an innovative working environment in a flat organization with an open-minded attitude and ability for our employees to make quick and sound decisions. We can offer you a varied, exciting, and occasionally challenging work with a lot of responsibility and a great deal of freedom.This position is fulltime and based at CellaVision HQ in Lund, Sweden with good infrastructure and commuting possibilities. Note that this position may require approximately 20 to 30 traveling days yearly.Ready to apply?Apply as soon as possible via the link in this post.We will work with continuous selection and interviews, so please send your application as soon as possible. We do not accept applications via email.Diversity is in our bloodAt CellaVision we understand not only the uniqueness of blood cells but also of people. We strongly believe in the power of diversity and recognize it as a driver of innovation. We are committed to building an inclusive culture for all our people.CellaVision is a non-discriminatory workplace where qualified applicants receive consideration for employment without regard to race, nationality, ethnic or social origin, age, religion, political orientation, sexual orientation, gender identity/expression, family or marital status, pregnancy, disability, or any other basis prohibited by law.More about usCellaVision was established in Sweden in 1994 with a vision to simplify, standardize, and digitize the manual analysis of blood cells in hematology laboratories. The company’s long-term success is a result of our commitment to innovation. Our goal is to provide value to patients, customers, and distributors by incorporating smart solutions into everything we do. Our research and development focus on offering superior analytical and diagnostic certainty by creating an ecosystem that combines reagents with hardware and software. Today CellaVision has 250 employees, with global Headquarters in Lund, Sweden.The company has market support offices in 16 markets and a presence in over 40 countries with reagent development and manufacturing performed in Martillac, France.For more information visit www.cellavision.com.To know more about the position, please contact recruiting manager Charlotte Oom, via e-mail: [email protected] decline all contact regarding services in advertising, consulting, or recruitment.Please note that you need a valid working permit in Sweden for this role. #J-18808-Ljbffr