Quality and Regulatory Affairs Manager - Healthcare Technology (f/m/d)

We are status quo breakers, game changers and pathway makers!With our health platform myoncare, we are transforming the healthcare market and, as a leading ecosystem, we want to enable excellent healthcare support for all patients in the world.How do we do that?People are at the center of everything we do!We connect all the players in the healthcare system to ensure that patients receive the right therapy, at the right time and to the right extent. All with the commitment and consent of the patient.Myoncare collects clinical patient data thanks to audited blockchain, without its own access, and ensures its security through encryption. For the first time, all patient care functions that previously existed as individual solutions or in incomplete form are bundled into one application!We have big plans - today and tomorrow! And that's why we are looking for innovators, change-makers and minds that are ready to take on new challenges.Talent and commitment are the key and that's why we need YOU! Come join the team and help us realise our mission.Myoncare offers you a space to flex your problem-solving muscles, develop and expand your skills and work on projects that really matter so you can grow with us.Experience the digital revolution of the healthcare system first hands as our newQuality and Regulatory Affairs Manager - Healthcare Technology (f/m/d).TasksPerform gap analyses of regulatory documents and QMS documentation, derive and implement required adaptations in documentation and processesKeep regulatory documentation such as laws, standards, regulations and guidance documents up-to-date and ensure continuous compliance of QMS and product to these requirementsIdentify and execute regulatory pathways for successful market accessActively promote improvement in QMS processesAdministration and maintenance of the QMS documentationAdvise other departments in daily regulatory and quality-related activitiesPlan and perform employee trainingsRequirementsAt least three years of experience in Regulatory Affairs or Quality Department for medical devices, ideally of medical device softwareAt least two years of experience in managing QM systems covering ISO 13485In-depth knowledge of MDR 2017/745, EN ISO 13485:2016, CFR part 820 and relevant sections of the FD&C ActExperience in generating and adapting SOPs and Working Instructions together with respective departments such as Research & Development and Product ManagementExperience in Regulatory Affairs in USA markets beneficialExperience in medical device vigilance beneficialKnowledge of ISO 14971, EN 62304 and EN 62366 beneficialIndependent working and a strong sense of responsibility for your own actionsDrive to identify potential for improvement and to find solutions for stakeholdersThoroughness in everything you do, a great attention to detail and the ability to quickly adapt to new problems even on tight schedulesExcellent time management and organizational skillsEffective communication in international and interdisciplinary teams and active listening skillsExcellent English proficiency (written and spoken), German proficiency is beneficialBenefitsCompetitive salary with performance-based growthCentral located office with plenty of lunch optionsPersonalized onboarding experienceGlobal team shaping the future of healthcareTeam eventsCoffee and tea stations for daily rechargeEmployee discountsNetworking opportunities with sister companies (sqanit & CONVIEN) for professional growthContribute to the digitalization of healthcare and take visionary step into the future with us!Become part of the ONCARE family and apply today with your complete application documents, stating your earliest possible starting date and your salary expectations.We are looking forward to hearing from you!Please not our data protection regulations on our homepage.