Thermo Fisher Scientific UK is seeking a Regulatory Specialist/Engineer III to support regulatory affairs by ensuring compliance with EU MDR/IVDR standards and providing regulatory support for product development across global sites. The position is remote, emphasizing teamwork, flexibility, and a commitment to improving global health and safety
Job Summary
The Regulatory Specialist will support the Laboratory Plastics Essentials business by working closely with global manufacturing sites including locations in Tijuana (MX), Monterrey (MX) and Roskilde (DE) to ensure overall product safety and regulatory compliance.
This position will be responsible for maintaining and updating Technical Documentation on regulated products and ensuring continuous improvement as it relates to changes in global standards and regulations.
The RA Specialist will also act as a regulatory consultant to ensure all products comply global and regional regulations and market needs (REACH/SVHC, California Proposition 65, RoHS).
Matching Summary
Match Score: 85
Thermo Fisher Scientific UK is seeking a Regulatory Specialist/Engineer III to support regulatory affairs by ensuring compliance with EU MDR/IVDR standards and providing regulatory support for product development across global sites. The position is remote, emphasizing teamwork, flexibility, and a commitment to improving global health and safety.
Skills & Requirements
Must-have
EU MDR/IVDR Technical Files
regulatory support
product development support
quality system processes
Nice-to-have
motivated by challenges
team-player mentality
continuous improvement approach
innovative problem-solving ability
Key Requirements
Minimum 2 years of experience
BA/BS degree in scientific or engineering field
US and EU Medical Device and In vitro Diagnostic requirements knowledge