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PPD (Thermo Fisher) is seeking a Regulatory Specialist/Engineer III to support regulatory activities in the medical device sector. The role involves maintaining compliance with EU and US regulations, updating technical files, and collaborating with global teams, all while working remotely.
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Job Summary
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale.
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.
Matching Summary
Match Score: 75
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PPD (Thermo Fisher) is seeking a Regulatory Specialist/Engineer III to support regulatory activities in the medical device sector. The role involves maintaining compliance with EU and US regulations, updating technical files, and collaborating with global teams, all while working remotely.
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Skills & Requirements
Must-have
EU MDR/IVDR Technical Files
product development regulatory strategies
regulatory plans and verification reports
customer requests in RA mailbox
product development reports review
risk evaluation in quality tasks
RA processes in QMS
external and internal audits support
Nice-to-have
motivated by challenges
team-player mentality
handle tasks independently
flexibility to handle shifting priorities
confidence in collaborating
continuous improvement approach
innovative problem-solving ability
Key Requirements
BA/BS degree in scientific or engineering field
At least 2 years of experience in regulated industry
Strong working knowledge of US and EU Medical Device and In vitro Diagnostic requirements