Innolitics LLC is a remote-first medical device consultancy hiring a Principal Regulatory Affairs Specialist to guide AI/ML-enabled SaMD through the FDA lifecycle. You will craft regulatory strategies, oversee clinical validation planning, and lead Pre-Submissions for strategic engagements.
The role emphasizes senior regulatory leadership, clear FDA communication, and collaboration with clients and Innolitics thought leadership. Remote work with occasional travel supports a global client base.
#J-18808-LjbffrRemote Principal Regulatory Affairs Strategist for SaMD AI in northern at Unknown Company
This position is listed as full time and able to be worked remotely.