Regulatory Affairs Specialist

vor 4 Wochen

Bremen, Bremen, Deutschland Bruker Vollzeit

About Us

Bruker is a leading company in the field of microorganism identification, and we are looking for a skilled Regulatory Affairs Specialist to join our team.

Job Summary

We are seeking a highly motivated and experienced Regulatory Affairs Specialist to ensure the regulatory compliance of our products. The successful candidate will be responsible for worldwide approval and registration of in-vitro diagnostics, implementation of conformity assessment procedures, and communication with sales partners and authorities.

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

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
  • Ideally, 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.

What We Offer

Bruker offers a dynamic and innovative work environment, with opportunities for professional growth and development. We provide a competitive salary and benefits package, as well as a flexible working environment that allows for a good work-life balance.

How to Apply

If you are a motivated and experienced Regulatory Affairs Specialist looking for a new challenge, please submit your application, including your resume and a cover letter, to us.

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