Cerus
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Cerus is seeking individuals to join their talent community, representing various opportunities in the future. The roles encompass a commitment to providing safe and accessible blood services globally, with a focus on recruiting qualified applicants.
The Sr. Trial Master File Manager will oversee the management and maintenance of Trial Master Files (TMFs), ensuring they remain inspection-ready and supporting regulatory submissions. Responsibilities include vendor oversight, budget management, TMF quality reviews, and training staff on eTMF systems. The role also involves performing quality checks and acting as a TMF subject matter expert for study teams.
The Scientist I will assist in laboratory supervision for registration studies, act as Study Director, analyze complex data, support regulatory submissions, and maintain expertise in biological sciences. Responsibilities include writing reports, mentoring associates, and working cross-functionally with clinical and regulatory teams.
The Device Engineer II / III will lead the design and development of new medical device technologies, support manufacturing activities, work with cross-functional teams, and ensure adherence to software lifecycle processes in a medical device environment.
The Quality Assurance Associate II is responsible for ensuring compliance with FDA regulations, ISO standards, and managing quality system deliverables. They lead audits, support supplier management activities, trend quality data, and assist in documentation for product release. They must possess strong problem-solving skills and attention to detail while adapting to changing priorities.