Regulatory Affairs Specialist
vor 12 Stunden
At Bruker, we are committed to innovation with integrity. As a Regulatory Affairs Specialist, you will play a crucial role in ensuring the regulatory compliance of our products worldwide.
We are seeking a highly motivated and experienced professional to join our team in Bremen, Germany. In this position, you will be responsible for worldwide approval and registration of in-vitro diagnostics, implementation of conformity assessment procedures for CE marking, and communication with sales partners, authorities, and notified bodies.
The ideal candidate will have a degree in biology, natural sciences, medical technology, or comparable qualifications, and relevant professional experience in regulatory affairs and/or quality management. Knowledge of regulatory relevant standards, guidelines, and the IVD Regulation (EU) 2017/746 is essential.
We offer a competitive salary of approximately €60,000 - €80,000 per year, depending on experience, as well as a harmonious work atmosphere, flexibility, and 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.
We are looking for a strong communicator with technical expertise who can work analytically, structured, precisely, and conscientiously. If you are passionate about regulatory affairs and want to contribute to the success of our company, please apply now.
In this role, you will be responsible for:
- Worldwide approval and registration of in-vitro diagnostics (EU and non-EU, including USA)
- 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
- Communication with sales partners, authorities and notified bodies
- Ensuring regulatory conformity in the respective target market
- Preparation of regulatory documents, incl. regulatory reports, technical dossiers and change notifications
- Regulatory assessments of changes
- Evaluation of regulatory and normative changes
Please note that a valid work permit is required for this position.
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