Senior Regulatory Affairs Specialist

Job Title: Senior Regulatory Affairs Specialist

Location: Saint Paul, MN 55112

Duration: 6 Months

Work Arrangement: 100% Onsite

Position Overview: 

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.

Top Skills and Experience:

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

Job Duties:

This position will support Regulatory Affairs activities with a primary focus on submission readiness, milestone tracking, and execution of Regulatory Affairs commitments supporting multiple concurrent global submissions. The individual will work closely with Regulatory Affairs team members and cross-functional partners to help ensure timely completion of regulatory deliverables and achievement of key submission milestones.

Responsibilities include:

• 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.

Years/Experience:

• 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

Skills:

• 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 PowerPoint
• Experience with project planning and tracking tools preferred

Education:

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

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.