Regulatory Affairs Lead Jobs in Minnesota
Regulatory Affairs Lead jobs in Minnesota are open across Plymouth, Minneapolis, and Arden Hills and other Minnesota metros, with employers like Abbott, Boston Scientific, and Covidien hiring at every experience level. Find a role that fits below and apply directly.
Find Regulatory Affairs Lead JobsOverview
Showing 5 of 13+ Regulatory Affairs Lead jobs
INTRODUCTION
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, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
- Career development with an international company where you can grow the career you dream of
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists
Structural Heart Business Mission: why we exist
Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.
This individual contributor role is based on-site at our St. Paul/New Brighton, MN facility within Abbott’s Structural Heart Division. The candidate will leverage expertise in scientific, regulatory, and business considerations to ensure products developed, manufactured, or distributed comply with all applicable regulations. This team member will support multiple product lines and therapies, serving as a recognized subject-matter expert and mentor within the department.
WHAT YOU’LL DO
- Prepare robust regulatory applications (FDA and international regulatory agencies) to achieve departmental and organizational objectives
- Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes
- Support pre and post approval submission activities
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
- Assess the acceptability of development, quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submissions to authorities
- Negotiate and interact with regulatory authorities during review process to ensure submission approval
- Ensure compliance with US and global product post marketing approval requirements
- Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
- Execute and manage technical and scientific regulatory activities. Must function independently as a decisionmaker on regulatory issues and must assure that deadlines are met
- Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements.
- Interface with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units
- Provide leadership and guidance towards achieving department objectives and act as a mentor to less-experienced staff
- May lead a cross-functional or cross-divisional project team
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures
Required Qualifications
- Bachelor's Degree in a related field OR an equivalent combination of education and work experience
- Minimum 4 years’ experience in a regulated industry (e.g., medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.
- Ability to effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with diverse audiences.
- Domestic and international regulatory guidelines, policies and regulations.
- Lead functional groups in the development of relevant data to complete a regulatory submission.
Preferred Qualifications
- Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
- Previous experience with US (e.g. PMA, PMA/S, IDE, 510(k), etc.), CE (EU MDR) and international submissions
- Experience with Class II and Class III medical devices
- Ability to define regulatory strategy. Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
- Experience with post-approval manufacturing and design changes
- Ability to work effectively on cross-functional teams
- Strong attention to detail
- Experience with organizing and tracking complex information. Able to juggle multiple and competing priorities
- Experience with exercising judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has broad knowledge of various technical alternatives and their potential impact on the business
- Uses in-depth knowledge of business functions and cross group dependencies/relationships
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
The base pay for this position is $99,300.00 – $198,700.00. In specific locations, the pay range may vary from the range posted.
INTRODUCTION
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, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
- Career development with an international company where you can grow the career you dream of
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists
Structural Heart Business Mission: why we exist
Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.
This individual contributor role is based on-site at our St. Paul/New Brighton, MN facility within Abbott’s Structural Heart Division. The candidate will leverage expertise in scientific, regulatory, and business considerations to ensure products developed, manufactured, or distributed comply with all applicable regulations. This team member will support multiple product lines and therapies, serving as a recognized subject-matter expert and mentor within the department.
WHAT YOU’LL DO
- Prepare robust regulatory applications (FDA and international regulatory agencies) to achieve departmental and organizational objectives
- Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes
- Support pre and post approval submission activities
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
- Assess the acceptability of development, quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submissions to authorities
- Negotiate and interact with regulatory authorities during review process to ensure submission approval
- Ensure compliance with US and global product post marketing approval requirements
- Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
- Execute and manage technical and scientific regulatory activities. Must function independently as a decisionmaker on regulatory issues and must assure that deadlines are met
- Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Properly interpret and apply regulatory requirements.
- Interface with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units
- Provide leadership and guidance towards achieving department objectives and act as a mentor to less-experienced staff
- May lead a cross-functional or cross-divisional project team
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures
Required Qualifications
- Bachelor's Degree in a related field OR an equivalent combination of education and work experience
- Minimum 4 years’ experience in a regulated industry (e.g., medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.
- Ability to effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with diverse audiences.
- Domestic and international regulatory guidelines, policies and regulations.
- Lead functional groups in the development of relevant data to complete a regulatory submission.
Preferred Qualifications
- Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
- Previous experience with US (e.g. PMA, PMA/S, IDE, 510(k), etc.), CE (EU MDR) and international submissions
- Experience with Class II and Class III medical devices
- Ability to define regulatory strategy. Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
- Experience with post-approval manufacturing and design changes
- Ability to work effectively on cross-functional teams
- Strong attention to detail
- Experience with organizing and tracking complex information. Able to juggle multiple and competing priorities
- Experience with exercising judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has broad knowledge of various technical alternatives and their potential impact on the business
- Uses in-depth knowledge of business functions and cross group dependencies/relationships
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
The base pay for this position is $99,300.00 – $198,700.00. In specific locations, the pay range may vary from the range posted.
See All 13 Regulatory Affairs Lead Jobs in Minnesota
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Find Regulatory Affairs Lead JobsRegulatory Affairs Lead Jobs by City in Minnesota
Where Minnesota roles are concentrated, by current openings.
Regulatory Affairs Lead Job Market in Minnesota
A snapshot from current Minnesota openings, updated as new roles post.
Who's Hiring
- Abbott5
- Boston Scientific1
- Covidien1
- Elucent Medical1
- Evalve1
Top Industries Hiring
- Biotechnology & Pharmaceuticals5
- Medical Devices4
- Chemicals & Materials1
- Distribution & Wholesale1
- Electronics & Hardware1
What Minnesota Employers Look For
The qualifications that appear most often in regulatory affairs lead jobs across Minnesota.
- Bachelor's degree or higher in life sciences, pharmacy, chemistry, or a related field
- Five or more years of experience managing regulatory submissions to FDA or comparable agencies
- Hands-on experience authoring or coordinating IND, NDA, BLA, 510(k), or PMA submissions
- Proficiency with electronic submission systems such as eCTD publishing tools or Veeva Vault RIM
- Regulatory Affairs Certification (RAC) from RAPS preferred or required by many employers
- Strong cross-functional communication skills for working with clinical, quality, and legal teams
Regulatory Affairs Lead Jobs in Minnesota: Frequently Asked Questions
How many regulatory affairs lead jobs are there in Minnesota?
There are 13+ regulatory affairs lead openings in Minnesota on Migrate Mate as of June 2026, with the most roles in Plymouth, Minneapolis, and Arden Hills. New positions post regularly as employers across Minnesota hire.
How much do regulatory affairs leads make in Minnesota?
Regulatory affairs leads in Minnesota earn a median of about $85,920 a year, based on May 2025 Bureau of Labor Statistics wage data, ranging from around $55,830 for the lowest 10% to over $134,040 for the top 10%. Pay rises with experience, specialty, and employer.
Which Minnesota cities have the most regulatory affairs lead jobs?
Plymouth, Minneapolis, and Arden Hills have the most regulatory affairs lead openings in Minnesota right now, with additional roles spread across smaller metros statewide.
Which companies hire regulatory affairs leads in Minnesota?
Employers hiring regulatory affairs leads in Minnesota include Abbott, Boston Scientific, and Covidien, based on current listings on Migrate Mate as of June 2026.
Are there remote regulatory affairs lead jobs in Minnesota?
Yes. About 23% of regulatory affairs lead openings tied to Minnesota are remote or hybrid as of June 2026. The rest are on-site roles based in Minnesota metros.
How do I apply for regulatory affairs lead jobs in Minnesota?
You can apply to regulatory affairs lead jobs in Minnesota directly on Migrate Mate. Search the listings above, find roles that match your experience and preferred Minnesota location, then apply to each one that fits.
See All 13 Regulatory Affairs Lead Jobs in Minnesota
Find roles in Minnesota that match your experience and apply in just a few clicks.
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