Regulatory Affairs Specialist
vor 4 Stunden
Bruker is seeking a highly skilled Regulatory Affairs Specialist to join our team in Bremen, Germany. As a Regulatory Affairs Specialist, you will be responsible for ensuring the regulatory compliance of our products, including in-vitro diagnostics, in the EU and non-EU markets, including the USA.
Key Responsibilities:- 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
- Degree in biology, natural sciences, medical technology or comparable qualifications
- Relevant professional experience in regulatory affairs and/or quality management is an advantage, applications from graduates are also welcome.
- Knowledge of regulatory relevant standards, guidelines and the IVD Regulation (EU) 2017/746
- Ideally, knowledge of software development process according to IEC 62304, IEC, 82304 and cybersecurity requirements within the EU and USA
- Strong communication skills and technical expertise when working with internal and external interfaces.
- Ability to work in an analytical, structured, precise and conscientious manner.
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