Are you interested to be part of something innovative?Join the Bruker regulatory team working on the MALDI Biotyper. Ourproduct is the standard in microorganism identification thatenables microbiology laboratories to identify microbes reliably andrapidly. It is used worldwide in many exciting application areasfrom new research groups to life saving healthcare institutions. Aspart of our team, you can help to ensure the regulatory complianceof our products, while working in a harmonious atmosphere. Toimprove the work life balance of employees, we allow flexibility inall manners, you decide whether you want to spend your flexibleworking hours from home or from the office. To ensure your healthwe offer company fitness possibilities, job bike, and companydoctors. To improve your professional skills, we offer individualadvanced trainings. Our office building is located in thetechnology park of Bremen, Horn Lehe and is easily accessible bybike, car, and public transport. When working in the office you mayspend your lunch time in our private cafeteria or in the greenparks around the building. As a strong employer in Bremen and Team11 Partner of Werder Bremen, Bruker recently opened a new buildingfor manufacturing, and our current Building in Horn Lehe is aboutto be renovated to a new modern workspace. Bruker as the team ofinnovation with integrity is looking forward to your application!We are looking as of now for our office in Bremen in full-time fora Regulatory Affairs Specialist (m/f/d) Aufgaben - Worldwideapproval and registration of in-vitro diagnostics (EU and non-EU,including USA) - Implementation of conformity assessment proceduresfor CE marking, preparation and maintenance of technicaldocumentation according to EU 2017/746, with focus on MedicalDevice Software - Communication with sales partners, authoritiesand notified bodies - Ensuring regulatory conformity in therespective target market - Preparation of regulatory documents,incl. regulatory reports, technical dossiers and changenotifications - Regulatory assessments of changes - Evaluation ofregulatory and normative changes Profil - Degree in biology,natural sciences, medical technology or comparable qualifications -comparable qualifications - Relevant professional experience inregulatory affairs and/or quality management is an advantage,applications from graduates are also welcome. - Knowledge ofregulatory relevant standards, guidelines and the IVD Regulation(EU) 2017/746 - Ideally, knowledge of software development processaccording to IEC 62304, IEC 81001-5-1, 82304 and cybersecurityrequirements within the EU and USA - You have strong communicationskills and technical expertise when working with internal andexternal interfaces. - You work in an analytical, structured,precise and conscientious manner. Wir bieten