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Remote Principal Regulatory Affairs Strategist for SaMD AI
Remote / Online - Candidates ideally in
Northern, Floyd County, Kentucky, USA
Listed on 2026-08-15
Northern, Floyd County, Kentucky, USA
Listing for:
Innolitics LLC
Full Time, Remote/Work from Home
position Listed on 2026-08-15
Job specializations:
-
Science
Medical Science Liaison, Healthcare Compliance
Job Description & How to Apply Below
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.
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