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Regulatory Affairs Program Manager Jobs in Minnesota

Abbott

MN

$64 - $68/hr

Regulatory Affairs Program Manager Location: Maple Grove, MN 55311 Duration: 12 Months Work Arrangement: Onsite Position Overview The Regulatory Affairs Program Manager will support the Global ...

Russell Tobin

Regulatory Affairs Specialist

Maplewood, MN · On-site

$30 - $35/hr

Manage U.S. product registrations and maintain regulatory documentation for assigned products ... program, legal support, auto, home insurance, pet insurance and employee discounts with preferred ...

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Regulatory Affairs Program Manager information

What does a regulatory affairs program manager do?

A Regulatory Affairs Program Manager oversees and coordinates regulatory activities to ensure that a company's products comply with all applicable laws and regulations. They manage submission processes for product approvals, communicate with regulatory agencies, and develop strategies to maintain compliance throughout the product lifecycle. Additionally, they collaborate with cross-functional teams such as research and development, quality assurance, and manufacturing to align regulatory requirements with business objectives. Their role is crucial in minimizing regulatory risks and accelerating the time to market for new products.

What are some typical challenges faced by regulatory affairs program managers when coordinating cross-functional teams?

Regulatory Affairs Program Managers often encounter challenges in aligning the objectives and timelines of different departments such as clinical, quality, and R&D. Balancing varying priorities, managing tight submission deadlines, and ensuring consistent communication between teams are common hurdles. Successful Program Managers proactively foster collaboration, clarify regulatory requirements, and facilitate regular updates to keep projects on track. Being able to anticipate and resolve conflicts, while adapting to evolving regulations, is key to driving effective program execution.

What are the key skills and qualifications needed to thrive as a regulatory affairs program manager, and why are they important?

To thrive as a Regulatory Affairs Program Manager, you need expertise in regulatory guidelines, project management, and a relevant science or healthcare degree. Familiarity with regulatory submission systems, document management tools, and certifications such as RAC (Regulatory Affairs Certification) are highly beneficial. Strong attention to detail, strategic communication, and collaborative problem-solving are crucial soft skills in this role. These competencies ensure efficient navigation of complex regulatory requirements, timely submissions, and successful product approvals.

What is the difference between Regulatory Affairs Program Manager vs Regulatory Affairs Specialist?

AspectRegulatory Affairs Program ManagerRegulatory Affairs Specialist
CredentialsTypically requires a bachelor’s degree in life sciences, regulatory affairs certification (RAC) preferredUsually holds a bachelor’s degree in life sciences or related field; RAC certification is a plus
Work EnvironmentManages multiple projects, oversees teams, and collaborates with cross-functional departmentsFocuses on preparing and submitting regulatory documents, supporting project teams
Employer & Industry UsageUsed in pharmaceutical, biotech, and medical device companies for leadership rolesCommonly employed in similar industries for entry- to mid-level regulatory roles

The Regulatory Affairs Program Manager oversees regulatory strategies and manages teams, while the Regulatory Affairs Specialist handles document preparation and submission. Both roles require relevant credentials and are vital in ensuring compliance within regulated industries.

Is regulatory affairs high paying?

Regulatory Affairs Program Managers typically earn competitive salaries that reflect their specialized knowledge of regulations, compliance, and industry standards. Salaries can vary based on experience, location, and the complexity of the regulatory environment, with many roles offering above-average compensation in the healthcare, pharmaceutical, and biotech sectors.

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For Regulatory Affairs Program Manager jobs in Minnesota, the most frequently searched job titles are:

What job categories do people searching Regulatory Affairs Program Manager jobs in Minnesota look for?

The top searched job categories for Regulatory Affairs Program Manager jobs in Minnesota are:

What cities in Minnesota are hiring for Regulatory Affairs Program Manager jobs?

Cities in Minnesota with the most Regulatory Affairs Program Manager job openings:

Regulatory Affairs Program Manager jobs near you

Regulatory Affairs Program Manager

Maple Grove, MN • On-site

Abbott

7.8

Company rating: 7.8 out of 10

Based on 138 frontline employees who took The Breakroom Quiz

174th of 544 rated manufacturers

People enjoy working here

Good employer

Recommended by parents

Learn more about Abbottexternal

$64 - $68/hr

Contractor

Medical, Dental, Vision, Life, Retirement

Re-posted 2 days ago

Job description

Job Title: Regulatory Affairs Program Manager
Location: Maple Grove, MN 55311
Duration: 12 Months
Work Arrangement: Onsite
Position Overview
The Regulatory Affairs Program Manager will support the Global Regulatory Services team and be responsible for managing large-scale regulatory programs across multiple medical device businesses. This role requires strong program and project management experience, cross-functional leadership, and the ability to drive complex initiatives from planning through execution.
Key Responsibilities
  • Lead large-scale regulatory programs spanning multiple functional areas and business units.
  • Manage the execution of projects and programs in accordance with the organization's program management methodology.
  • Develop, prioritize, and manage project plans, budgets, timelines, and methodologies.
  • Define project resources, milestones, deliverables, and lead cross-functional teams to achieve program goals.
  • Take ownership of multiple related projects that collectively comprise a program.
  • Lead complex and/or critical programs, including Extended Producer Responsibility (EPR) initiatives.
  • Establish, review, and own program charters while partnering with program sponsors for approvals.
  • Monitor program progress, performance, budgets, timelines, and overall program health.
  • Re-evaluate program direction based on project status and business objectives.
  • Identify risks, resolve program issues, and minimize project delays.
  • Build and manage relationships across business units and project teams.
  • Support and mentor local Program Managers in implementing standardized processes.
  • Coordinate with the Corporate PMO to manage implementation schedules and budgets.
  • Develop sustainable processes and best practices across business locations.
  • Lead meetings, prepare presentations, and provide regular status updates to senior leadership.
  • Provide training, implementation planning, and ongoing support to program participants.
  • Evaluate external consultants to optimize project costs and business value.

Required Experience
  • Minimum 5 years of Program/Project Management experience.
  • Experience managing large-scale cross-functional programs.
  • Experience developing project plans, budgets, timelines, and resource allocation.
  • Experience leading cross-functional teams and managing multiple projects simultaneously.

Preferred Qualifications
  • Background in Program/Project Management.
  • Experience within Regulatory Affairs, Medical Device, or other regulated industries preferred.
  • Strong leadership, communication, and stakeholder management skills.
  • Experience working with Project Management Office (PMO) methodologies.

Education
  • Bachelor of Science 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.
  • Published on 24 Jul 2026, 11:29 PM

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