Senior Regulatory Affairs Specialist

Role: Senior Regulatory Affairs Specialist for medical devices and in vitro diagnostics, focusing on regulatory submissions and compliance across domestic and international markets. Responsibilities: develop and execute strategies for FDA (510(k), PMA, IDE) and ex-U.S. submissions, interpret global regulations (U.S. and EU), guide product development teams, prepare documentation, monitor clinical study status, review labels and promotional materials, and respond to agency requests. Qualifications: Bachelor's in biological sciences or related field, minimum 5 years in device, diagnostic, or pharma regulatory affairs; strong knowledge of U.S., EU, and global regulatory requirements; experience with GLP, QSR, and quality systems. High-Value: expertise in medical device and IVD regulation, clinical study review, regulatory strategy, and international registration; remote work in the USA; no travel specified.