Regulatory Affairs Specialist

vor 1 Woche

Bremen, Bremen, Deutschland Bruker Vollzeit

Overview

Bruker is seeking a highly skilled Regulatory Affairs Specialist to join our team in Bremen, Germany. As a key member of our regulatory team, you will be responsible for ensuring the compliance of our products with regulatory requirements worldwide.

Key Responsibilities

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

Requirements

  • 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
  • Ideal knowledge of software development process according to IEC 62304, IEC 81001-5-1, 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

About Bruker

Bruker is a leading manufacturer of scientific instruments for research and industry. Our products are used in a wide range of applications, from materials science to life sciences. We are committed to innovation and excellence in all aspects of our business.

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