Regulatory Affairs Specialist
vor 3 Wochen
About Bruker
Bruker is a leading manufacturer of innovative analytical and scientific instruments for various industries, including life sciences and materials research.
Job Summary
We are 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, particularly in-vitro diagnostics, in the EU and non-EU markets, including the USA.
Key Responsibilities
- Obtain worldwide approvals and registrations for in-vitro diagnostics, including EU and non-EU markets, and 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.
- Conduct regulatory assessments of changes and 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 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 the Team
You will be part of a harmonious team that values work-life balance and offers flexibility in all manners. Our office building is located in the technology park of Bremen, Horn Lehe, and is easily accessible by bike, car, and public transport.
What We Offer
- Flexible working hours and the possibility to work from home or the office.
- Company fitness possibilities, job bike, and company doctors to ensure your health.
- Individual advanced trainings to improve your professional skills.
Language
The working language is English (en-US).
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