Senior Regulatory Affairs Specialist

Job Title: Senior Regulatory Affairs Specialist
Location: 1225 Old Highway 8 NW, Saint Paul, MN 55112
Duration: 6 Months
Work Arrangement: 100% Onsite
Pay Range: $50 - $53 per hour (W2)

We are seeking a “Senior Regulatory Affairs Specialist” to join one of our leading healthcare clients.

Submission Readiness & Execution. Provide Regulatory Affairs support for multiple global submissions by coordinating submission readiness activities, tracking Regulatory Affairs deliverables, supporting compilation of submission documentation, and helping ensure key regulatory milestones are achieved. This role partners closely with Regulatory Affairs leads and project teams to maintain visibility to commitments, proactively identify risks, and support timely submission execution.

• Deliverable & Timeline Management
• Regulatory Submission Coordination
• Cross-Functional Coordination

• Maintain Regulatory Affairs deliverable trackers and monitor progress against established submission timelines.
• Conduct routine reviews of regulatory deliverables, action items, and dependencies to support submission readiness.
• Work closely with Regulatory Affairs leads to identify, communicate, and help address risks to planned regulatory milestones and submission dates.
• Collaborate with project management and cross-functional teams to ensure Regulatory Affairs activities and milestones are accurately reflected in project schedules and planning tools.
• Support preparation of regulatory status updates, milestone reviews, dashboards, and management communications.
• Coordinate Regulatory Affairs meetings supporting submission planning, review activities, and issue resolution.
• Assist with compilation, organization, and maintenance of regulatory documentation in accordance with established procedures.
• Support preliminary regulatory assessments and coordination activities associated with product, manufacturing, or labeling changes under direction of Regulatory Affairs personnel.

• Minimum 2+ years of regulatory affairs experience or related medical device experience
• Experience supporting global regulatory submissions and registration activities
• Experience working within complex, cross-functional product development environments
• Experience utilizing project planning tools, milestone trackers, and Gantt schedules preferred
• Experience supporting multiple concurrent projects and managing competing priorities

• Working knowledge of medical device regulatory processes and submissions
• Strong organizational, communication, and follow-up skills
• Ability to monitor and track complex deliverables across multiple stakeholders
• Experience supporting preparation and review of regulatory submission documentation
• Strong attention to detail and problem-solving skills
• Ability to proactively identify risks, gaps, and timing concerns impacting regulatory deliverables
• Experience preparing status updates and management reports
• Proficiency in Microsoft Office applications, including Excel and Power Point
• Experience with project planning and tracking tools preferred

• Bachelor's Degree in a scientific, engineering, regulatory affairs, business, or related discipline required