Role: Regulatory Affairs Manager (Project Manager, Individual Contributor) Location: St. Paul, MN Duration: 6 Months Shift: 08:00 AM to 05:00 PM Core Responsibilities: Regulatory Expertise: Develop and implement regulatory strategies for timely product approval. Prepare and submit regulatory documentation (IDE, PMA, CE Mark applications, EU MDR clinical trial applications, etc.). Ensure compliance with FDA, EU MDR, and other international regulatory requirements. Project Management: