Senior Medical Safety Quality Specialist | Apheresis Clinical Expertise

3 weeks ago


Littleton, Colorado, United States Terumo BCT Full time
About Terumo Blood and Cell Technologies

We are proud to be a leading global medical device company dedicated to improving patient outcomes through innovative technologies and solutions. With a strong commitment to quality and safety, we strive to make a positive impact on people's lives.

Job Summary

We are seeking a highly skilled Senior Medical Safety Quality Specialist to join our team. As a key member of our global organization, you will play a critical role in ensuring the safety and performance of our post-market apheresis medical devices.

Key Responsibilities
  • Provide clinical and apheresis expertise in identifying and evaluating adverse event reports and investigations.
  • Lead investigations for reportable adverse event complaints, potentially resulting in Field Action Evaluation decisions.
  • Conduct evaluations of medical device performance and clinical data, assessing impact on product safety.
  • 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.
  • Assist in developing product training and technical review standardization specific to adverse event incidents and complaints.
  • Collaborate across functions to ensure regulatory compliance and quality system adherence.
Requirements
  • Bachelor's degree in nursing (apheresis preferred), biological sciences, or above.
  • Licensed healthcare professional (e.g., RN, PA, NP) with at least three years of clinical experience in apheresis; or, with an advanced degree (Master's or above, MD), at least two years of clinical experience in apheresis.
  • Preferred: 3+ years relevant experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical).
  • Preferred: 2+ years leveraging medical knowledge as an advocate for patient safety by providing medical safety input to internal functions and business processes across the product life cycle.
  • Preferred: Experience in transfusion medicine, blood banking, cellular therapy, and/or apheresis.
What We Offer

We are committed to providing a competitive total reward package that includes a salary range of $82,700.00 to $103,000.00 based on education, experience, knowledge, skills, and abilities, plus a 7.0% bonus on base. Our benefits package includes multiple group medical, dental, and vision plans, a robust wellness program, life insurance and disability coverages, and a variety of voluntary programs.

About Our Company Culture

At Terumo Blood and Cell Technologies, we value our employees and strive to create a positive work environment. We are committed to diversity, equity, and inclusion, and we welcome applications from individuals from diverse backgrounds. We are an equal opportunity employer and do not discriminate based on race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status, or an unfavorable discharge from military service.



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