FDA 510k Regulatory Lead for Software Medical Devices

LennTech Search is seeking an experienced Regulatory Affairs Manager for a software medical device environment. You will lead regulatory submissions, manage 510(k) Q-Submissions, and coordinate reports to regulatory bodies, ensuring post-market surveillance aligns with current regulations.

The role requires knowledge of regulatory requirements in the US, Canada, and China, plus experience in startups or fast-growing companies. Join a dynamic team driving innovative medical software solutions.