
Regulatory & Quality Lead, SaMD & FDA Submissions
MedTech Innovator, Dallas, TX, United States
A dynamic digital health company in Dallas seeks a Medical Quality & Regulatory Specialist to manage its Quality Management System and ensure compliance with FDA and ISO standards. This key role involves documenting processes, supporting regulatory submissions, and collaborating with cross-functional teams. Ideal candidates will have a Bachelor’s degree, 3+ years in quality/regulatory roles, and knowledge of medical device regulations. Join a mission-driven company focused on innovative stroke care solutions and enjoy competitive compensation and flexible work culture.
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