Regulatory Affairs Specialist | Regulatory Affairs Specialist (m/w/d)
Thermo Electron LED GmbH
Job Summary
This role is for a Regulatory Affairs Specialist to join Thermo Fisher Scientific in Langenselbold, Germany. The specialist will be crucial in coordinating, evaluating, and implementing global regulatory affairs strategies and compliance programs. Day-to-day, you'll act as a liaison between internal departments and external authorities, ensuring product designs and changes meet all applicable norms and regulations. You will also support customers with compliance inquiries, contribute to reducing product liability, and participate in compliance reviews for both internal and OEM projects. This position offers a dynamic international environment within a leading scientific company, focusing on ensuring products like microbiological safety cabinets and CO2 incubators meet global standards.
Required Skills
Education
Degree in Life Science, Engineering, or comparable qualification
Experience
- Professional experience in Regulatory Affairs
- Experience applying FDA and ISO quality standards (advantageous)
- Experience in problem-solving, particularly with new regulatory requirements or product liability risk assessments
- Experience working in an interdisciplinary environment
Languages
Additional
- Willingness to travel (approx. 20%) nationally and internationally (e.g., North and South America, Asia-Pacific)