QA/RA Manager within Medtech – Visiana – Søborg

Make an impact on medical device development as part of an experienced team making a difference to children undergoing orthopedic treatment worldwide.This is a rare opportunity to take responsibility, expand your knowledge, and exercise your skills in regulatory affairs(RA) and quality assurance(QA) as RA/QA manager in a small but mature organization.We are now looking for you to maintain and further develop and improve our ISO 13485:2016 certified electronic quality management system to enable market access in more markets.Your primary focus will be on organizational- and product-specific quality assurance and ensuring an overview of regulatory requirements in a hands-on approach assisting the organization in maintaining an efficient implementation of the QMS.What we doVisiana has developed the software BoneXpert which through artificial intelligence automatically interprets a digital X-ray of a child’s hand. BoneXpert determines how old the child is according to its biological clock, and this is used e.g. in relation to growth hormone treatment, and to predict how high the child will become as an adult. This interpretation was traditionally performed by a radiologist, but our software is able to replace the radiologist’s work. The software is already Class I CE-marked, but will within the next 2-3 years switch to Class IIa under MDR.Fields of responsibility / opportunity * Maintaining and improving the effectiveness of the QMS. * Product realization (without responsibility for clinical aspects, usability, and PMS). * Handling documentation packages for FDA / MDR and different authorities. * Communication with representatives from different countries. * Continual improvement and development of the quality management system * Proactively engage with the organization to ensure effective compliance to set procedures and regulations * Overseeing internal and external audits. * Facilitate communications with authorities * Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market requirements for our product BoneXpert and ensure alignment with our overall business strategy * Ensure that regulated processes and systems in Visiana are always inspection-ready * Serve as PRRC * Other team projects, as assigned Your qualifications (not necessarily all) * A relevant background in QA/RA, as a health care professional, or in software development. * 2-4 years of experience in the Medtech industry. * Experience with medical device regulations for EU and US. * Good knowledge of ISO13485:2016. * Interest and willingness to work systematically and document work in our QMS. * Interest in contact with authorities, customers, and external quality assurance experts. * Interest in new technologies and streamlining processes where it makes sense. * You can work independently and engage in constructive interaction with your new colleagues. * You have excellent English skills, additional languages are an advantage. * You have good analytical and technical skills.

Read more…