Überblick
Are you interested to be part of something innovative? Join the Bruker regulatory team working on the MALDI Biotyper. Our product is the standard in microorganism identification that enables microbiology laboratories to identify microbes reliably and rapidly. It is used worldwide in many exciting application areas from new research groups to life saving healthcare institutions.
As part of our team, you can help to ensure the regulatory compliance of our products, while working in a harmonious atmosphere. To improve the work life balance of employees, we allow flexibility in all manners, you decide whether you want to spend your flexible working hours from home or from the office. To ensure your health we offer company fitness possibilities, job bike, and company doctors. To improve your professional skills, we offer individual advanced trainings.
Our office building is located in the technology park of Bremen, Horn Lehe and is easily accessible by bike, car, and public transport. When working in the office you may spend your lunch time in our private cafeteria or in the green parks around the building.
As a strong employer in Bremen and Team 11 Partner of Werder Bremen, Bruker recently opened a new building for manufacturing, and our current Building in Horn Lehe is about to be renovated to a new modern workspace.
Bruker as the team of innovation with integrity is looking forward to your application!
We are looking as of now for our office in Bremen in full-time for a Regulatory Affairs Specialist (m/f/d)
Aufgaben/Verantwortlichkeiten
1. Worldwide approval and registration of in-vitro diagnostics (EU and non-EU, including USA)
2. Implementation of conformity assessment procedures for CE marking, preparation and maintenance of technical documentation according to EU 2017/746, with focus on Medical Device Software
3. Communication with sales partners, authorities and notified bodies
4. Ensuring regulatory conformity in the respective target market
5. Preparation of regulatory documents, incl. regulatory reports, technical dossiers and change notifications
6. Regulatory assessments of changes
7. Evaluation of regulatory and normative changes
Qualifikationen
8. Degree in biology, natural sciences, medical technology or comparable qualifications
9. comparable qualifications
10. Relevant professional experience in regulatory affairs and/or quality management is an advantage, applications from graduates are also welcome.
11. Knowledge of regulatory relevant standards, guidelines and the IVD Regulation (EU) 2017/746
12. Ideally, knowledge of software development process according to IEC 62304, IEC 81001-5-1, 82304 and cybersecurity requirements within the EU and USA
13. You have strong communication skills and technical expertise when working with internal and external interfaces.
14. You work in an analytical, structured, precise and conscientious manner.