Senior Medical Safety Quality Professional

5 days ago


Lakewood, Washington, United States Terumo BCT Full time

We are seeking an experienced Senior Medical Safety Quality Specialist to join our team at Terumo Blood and Cell Technologies. This role is responsible for ensuring the safety and performance of post-market apheresis medical devices throughout their product lifecycle.

The ideal candidate will have extensive patient-facing apheresis clinical experience and knowledge, as well as strong technical and clinical skills. As a key member of our team, you will lead and participate in safety signal identification, evaluation, and management for marketed products.

Key responsibilities include providing clinical and apheresis expertise in identifying and evaluating adverse event reports and investigations, leading investigations for reportable adverse event complaints, and conducting evaluations of medical device performance and clinical data.

In addition, you will perform literature searches and initiate complaint investigations based on findings, provide evidence-based medical safety input and education on safety inquiries from internal or external stakeholders, and collaborate across functions to ensure regulatory compliance and quality system adherence.

This role requires strong communication and problem-solving skills, with the ability to work independently and collaboratively as part of a global team.

Estimated Salary Range: $82,700 - $103,400Bonus: 7.0% of base salary

Terumo Blood and Cell Technologies offers a competitive total reward package, including multiple group medical, dental, and vision plans, a robust wellness program, life insurance, disability coverages, and more.

Located in Lakewood, Colorado, this role offers a unique opportunity to make a meaningful impact in the lives of patients worldwide.



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