Global Clinical Regulatory Writer & SLR Lead
Listed on 2026-10-06
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Pharmaceutical
Regulatory Compliance Specialist, Healthcare Compliance
Terumo Blood and Cell Technologies in Lakewood, CO is seeking a Global Clinical Regulatory Specialist to lead CER and PMCF development, reviews, and documentation for TBCT devices.
The role requires 5 years in clinical evaluation, regulatory writing, and literature reviews, with MS/PhD preferred, collaboration across Safety, QA, Regulatory Affairs, and Product teams.
You will manage SLR inputs, maintain compliance with CE Marking, IDE, PMA, and 510(k), and prepare final CER and PMCF reports.
We are seeking a motivated Global Clinical Regulatory Writer & SLR Lead to join TERUMO BCT, INC in Lakewood, CO, United States.
For the Global Clinical Regulatory Writer & SLR Lead position at TERUMO BCT, INC, we are reviewing applications now.
Step into the Global Clinical Regulatory Writer & SLR Lead role at TERUMO BCT, INC in Lakewood, CO, United States and grow with us.
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