Senior Regulatory Affairs Specialist
Columbus, Franklin County, Ohio, 43224, USA
Listed on 2026-10-09
-
Healthcare
Healthcare Compliance, Medical Science Liaison
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.
This posting is for the Senior Regulatory Affairs Specialist role at Scorpion Therapeutics, based in United States.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).