Regulatory Affairs Specialist

Vor 3 Tagen

Bremen, Bremen, Deutschland Bruker Vollzeit

About the Role

Bruker is seeking a highly skilled Regulatory Affairs Specialist to join our team in Bremen, Germany. As a key member of our software development team, you will be responsible for ensuring the regulatory compliance of our products, particularly in the area of in-vitro diagnostics.

Key Responsibilities

  • Obtain worldwide approval and registration of in-vitro diagnostics, including EU and non-EU countries, as well as the USA.
  • Implement conformity assessment procedures for CE marking and prepare and maintain technical documentation according to EU 2017/746, with a focus on Medical Device Software.
  • Communicate with sales partners, authorities, and notified bodies to ensure regulatory conformity in the respective target market.
  • Prepare regulatory documents, including regulatory reports, technical dossiers, and change notifications.
  • Evaluate regulatory and normative changes to ensure compliance.

Requirements

  • Degree in biology, natural sciences, medical technology, or a comparable field.
  • Relevant professional experience in regulatory affairs and/or quality management is an advantage, but applications from graduates are also welcome.
  • Knowledge of regulatory relevant standards, guidelines, and the IVD Regulation (EU) 2017/746.
  • Ideal 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.
  • Analytical, structured, precise, and conscientious work approach.

About Bruker

Bruker is a leading manufacturer of scientific instruments and software for various industries, including life sciences, materials research, and chemistry. Our products are used worldwide in many exciting application areas, from new research groups to life-saving healthcare institutions. We offer a harmonious work atmosphere, flexibility in working hours, company fitness possibilities, job bike, and company doctors to ensure a healthy work-life balance. We also provide individual advanced trainings to improve your professional skills.

Location

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.

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