Regulatory Affairs Specialist mfd

Bruker Corporation; Ettlingen; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading company in scientific instruments is seeking a Regulatory Affairs Specialist for a limited 2-year contract in Ettlingen. The role involves supporting regulatory compliance throughout the product lifecycle, managing audits, and coordinating regulatory strategies for new products. Ideal candidates will have a degree in Engineering and 3-5 years of experience in Regulatory Affairs or related fields.

Qualifikationen

• 3-5 years of practical experience in Regulatory Affairs or related fields.
• Experience with IEC / EN 62304 and IEC / EN 62366 standards.
• Knowledge of EMC and electrical safety standards.

Aufgaben

• Support regulatory affairs throughout the product lifecycle.
• Establish and update processes for compliance with regulations.
• Communicate with authorities and manage audits and inspections.

Kenntnisse

Conflict Management

Autonomous Working

Organizational Skills

Solution-oriented Mindset

Team Player Attitude

Ausbildung

Diploma or Master's degree in Engineering (Electrical or Mechanical)

Jobbeschreibung

About Bruker Corporation: Leader of the PostGenomic Era

Bruker enables scientists and engineers to make breakthrough postgenomic discoveries and develop new applications that improve the quality of human life. Our high-performance scientific instruments and analytical solutions facilitate exploration at molecular, cellular, and microscopic levels. In collaboration with our customers, Bruker drives innovation, productivity, and success in postgenomic life sciences, molecular and cell biology research, applied and biopharma applications, microscopy, nanoanalysis, industrial, and cleantech research, as well as next-generation semiconductor metrology supporting AI. We offer specialized high-value systems and solutions in preclinical imaging, clinical phenomics, proteomics, multiomics, spatial and single-cell biology, structural biology, condensate biology, clinical microbiology, and molecular diagnostics.

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

We are seeking a Regulatory Affairs Specialist (m/f/d) for our division in Ettlingen. This is a limited 2-year contract to cover maternity leave.

Responsibilities

1. Support regulatory affairs throughout the product lifecycle (development, certification, registration, marketing materials, post-market surveillance).
2. Establish and update processes to ensure compliance with changing regulations, including environmental regulations (REACH, RoHS).
3. Communicate with authorities and regulatory agencies (EU and worldwide), manage audits and inspections.
4. Coordinate and implement regulatory strategies for new and existing products.
5. Assist in registering and launching new products.
6. Support post-market surveillance and CAPA activities from a regulatory perspective.
7. Assist with NRTL certification and factory inspections.

Qualifications

• Diploma or Master's degree in Engineering (Electrical or Mechanical).
• Optional: Additional qualifications in Software Life Cycle processes.
• Experience with IEC / EN 62304 and IEC / EN 62366 standards.
• Knowledge of EMC and electrical safety standards (IEC / EN 61010, IEC / EN 60601).
• Minimum of 3-5 years of practical experience in Regulatory Affairs or related fields such as Quality, preferably in instrumentation, electrical, or electronic industries.

Skills and Attributes

• Ability to manage conflicts effectively.
• Autonomous working style.
• Strong organizational skills.
• Solution-oriented mindset and team player attitude.

Fluent in English and German.

If this opportunity interests you, we look forward to getting to know you!

Additional Details

• Employment Type: Full-Time
• Experience: 3-5 years preferred
• Vacancy: 1