Regulatory Affairs Specialist (m/f/d)

Bruker; Ettlingen; Vor Ort; EUR 40.000 - 60.000; Vollzeit

Zusammenfassung

Ein etabliertes Unternehmen sucht einen Regulatory Affairs Specialist, der den gesamten Produktlebenszyklus unterstützt, einschließlich Entwicklung, Zertifizierung und Markteinführung. In dieser spannenden Rolle arbeiten Sie an der Einhaltung von Vorschriften in einem sich ständig ändernden regulatorischen Umfeld. Sie werden die Verantwortung für die Koordination und Umsetzung von regulatorischen Strategien für neue Produkte übernehmen und dabei eng mit Behörden und internationalen Agenturen zusammenarbeiten. Wenn Sie eine Leidenschaft für regulatorische Angelegenheiten haben und in einem dynamischen Team arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Qualifikationen

• 3-5 Jahre Erfahrung im Bereich Regulatory Affairs oder verwandten Bereichen.
• Diplom/Master-Abschluss in Ingenieurwesen erforderlich.

Aufgaben

• RA-Unterstützung während des gesamten Produktlebenszyklus.
• Kommunikation mit Behörden und Durchführung internationaler Audits.

Kenntnisse

Regulatory Affairs

Conflict Management

Organizational Skills

Solution-oriented Work

Team Collaboration

Fluent in English

Fluent in German

Ausbildung

Diplom/Master's degree in Engineering

Advanced Training in Risk Management

Basic Experience with IEC/EN Standards

Tools

Risk Management Standards (EN ISO 1471)

IEC/EN 62304

IEC/EN 62366

IEC/EN 61010

IEC/EN 60601

Jobbeschreibung

Überblick

About Bruker Corporation – Leader of the Post-Genomic Era

Bruker is enabling scientists and engineers to make breakthrough post-genomic discoveries and develop new applications that improve the quality of human life. Bruker’s high performance scientific instruments and high value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular, and microscopic levels. In close cooperation with our customers, Bruker is enabling innovation, improved productivity, and customer success in post-genomic life science molecular and cell biology research, in applied and biopharma applications, in microscopy and nanoanalysis, as well as in industrial and cleantech research, and next-gen semiconductor metrology in support of AI. Bruker offers differentiated, high-value life science and diagnostics systems and solutions in preclinical imaging, clinical phenomics research, proteomics and multiomics, spatial and single-cell biology, functional structural and condensate biology, as well as in clinical microbiology and molecular diagnostics.

For more information, please visit www.bruker.com.

For our Division in Ettlingen we are searching for Regulatory Affairs Specialist (m/f/d).

This is a limited 2 years contract for a maternity leave replacement.

Aufgaben/Verantwortlichkeiten

• RA support during the whole product life cycle (development, certification/registration/marketing material/post market surveillance)
• Establish and update processes in your area of responsibility for staying in compliance in a changing regulatory environment, including environmental regulations (Reach, RoHS…)
• Lead/support communication (registration/reporting) with authorities/regulatory agencies/designated bodies (EU and worldwide) and manage international audit/inspection programs as required.
• Coordinate, manage and implement regulatory strategies for new and established products.
• Lead/support efforts to register and launch new products.
• Lead/support post market surveillance activities from a regulatory perspective.
• Lead/support CAPA activities from a regulatory perspective.
• Supporting NRTL certification, Factory Inspection.

Does this sound interesting to you?

Qualifikationen

• Diplom/Master's degree in Engineering (electrical/mechanical)
• Optional: Advanced training, additional qualifications:
  • Risk Management (EN ISO 1471)
  • Software Life Cycle processes
  • Basic Experience with IEC/EN 62304 and IEC/EN 62366
  • Knowledge of EMC, electrical safety standards (IEC/EN 61010, IEC/EN 60601)
• Minimum 3-5 years practical experience in Regulatory Affairs or connected field (i.e. Quality), preferred analytical instrumentation, electrical, electronic industry.
• Ability to manage conflict situations.
• Able to work autonomously.
• Organizational skills.
• Solution-oriented work and Team-Player.
• Fluent in English and German.

Then get started today – we are keen to get to know you!