Regulatory Affairs Expert

3 weeks ago


California, United States BioTalent Full time

BioTalent is seeking a seasoned Regulatory Affairs Specialist to drive regulatory strategies and submissions for medical devices. As a key member of our team, you will develop and implement global regulatory strategies for clinical applications in various markets. Your expertise will be crucial in managing regulatory submissions, collaborating with clinical and cross-functional teams, and ensuring compliance with adverse event reporting. If you have a strong background in FDA regulations, EU MDR, and ISO 13485, and experience with high-risk devices, we encourage you to apply. Our company offers a competitive salary, stock options, 401k, and health insurance plans, as well as paid time off, flexible schedule, wellness programs, and growth opportunities. We are committed to diversity and providing equal employment opportunities to all individuals.



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