Regulatory Project Manager

Hello,

My name is Thomas Gillitzer and I am a Recruiter with The Fountain Group.  We are a national staffing firm and are currently seeking a ­­­­­­­­ Project Manager – FDA 510(k) Submission for a prominent client of ours.  This position is located in ­­Remote (Madison, WI). Details for the position are as follows:

Job Description: $60-$65 Hourly

• Coordinate the cross functional work effort to complete all necessary components to submit a new SaMD AI risk model product to the FDA for 510(k) clearance.
• The Clinical Surveillance & Compliance (CSC) business unit is pursuing FDA 510(k) clearance for a new machine learning (ML) clinical risk model that is considered regulated as software as a medical device (SaMD) by the FDA. The regulatory strategy includes pre-submission to the FDA for review of the proposed clinical study, then submission under a 510(k) clearance with an identified predicate device.
• Under the guidance of expert counsel and legal and regulatory staff, Project Manager will identify all required documents and documentation, understand their required content and format, and build a plan to meet submission deadlines. Project Manager will work with the department leaders and subject matter experts in all relevant internal business teams, Health data science team, and with legal and compliance to draft required documents, gather required existing documentation, and manage the project to complete the 510(k) submission by the timelines in the project plan.
• 4+ years of experience managing FDA 510(k) submissions 
• Experience managing the project submission of at least three software as medical device (SaMD) submissions 
• Background and/or education in the healthcare industry with specific knowledge of hospital information technology preferred.

If you are interested in hearing more about the position please respond to this posting