Regulatory Affairs Specialist (m/f/d)

Bruker Corporation; Ettlingen; Vor Ort; EUR 50.000 - 75.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Regulatory Affairs Specialist to support product life cycles and ensure compliance in a dynamic regulatory environment. This role involves managing communication with regulatory agencies and implementing strategies for product registration and launch. With a focus on innovation in scientific instruments, this position offers an exciting opportunity to contribute to advancements in life sciences and diagnostics. If you are a proactive team player with a strong background in regulatory affairs, this is your chance to make a significant impact.

Qualifikationen

• 3-5 years of experience in Regulatory Affairs or related fields.
• Fluency in English and German (C1 level minimum).

Aufgaben

• Provide RA support throughout the product life cycle.
• Coordinate regulatory strategies for new and existing products.

Kenntnisse

Regulatory Affairs

Risk Management

Conflict Management

Organizational Skills

Solution-oriented

Ausbildung

Diplom/Master's degree in Engineering

Tools

IEC/EN 62304

IEC/EN 60601

IEC/EN 61010

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 fostering innovation, improved productivity, and customer success across various fields including post-genomic life science, molecular and cell biology research, applied and biopharma applications, microscopy and nanoanalysis, industrial and cleantech research, and next-generation semiconductor metrology supporting 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 clinical microbiology and molecular diagnostics.

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

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

This is a limited 2-year contract for a maternity leave replacement.

Aufgaben/Verantwortlichkeiten

• Provide RA support throughout the product life cycle, including development, certification, registration, marketing material, and post-market surveillance.
• Establish and update processes within your area to ensure compliance in a changing regulatory environment, including environmental regulations (REACH, RoHS, etc.).
• Lead/support communication with authorities, regulatory agencies, and designated bodies (EU and worldwide), and manage international audit and inspection programs as required.
• Coordinate, manage, and implement regulatory strategies for new and existing products.
• Lead/support efforts to register and launch new products.
• Support post-market surveillance activities from a regulatory perspective.
• Support CAPA activities from a regulatory perspective.
• Assist with NRTL certification and factory inspections.

Does this sound interesting to you?

Qualifikationen

• Diplom/Master's degree in Engineering (Electrical/Mechanical).
• Fluent in English and German (minimum C1 level).
• Optional: Advanced training or additional qualifications such as:
  • Risk Management (EN ISO 1471).
  • Software Life Cycle processes.
  • Basic experience with IEC/EN 62304 and IEC/EN 62366.
  • Knowledge of EMC and electrical safety standards (IEC/EN 61010, IEC/EN 60601).
• Minimum of 3-5 years practical experience in Regulatory Affairs or related fields like Quality, preferably in analytical instrumentation, electrical, or electronic industries.
• Ability to manage conflict situations.
• Able to work autonomously.
• Strong organizational skills.
• Solution-oriented and a team player.

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