Regulatory Affairs Analyst Jobs in Minnesota
Regulatory affairs analyst jobs in Minnesota are concentrated in the Twin Cities metro, with additional hiring in Rochester and Duluth, driven by the state's deep base of medical device, pharmaceutical, and food and agriculture companies. Employers like Medtronic, Boston Scientific, and General Mills consistently post regulatory affairs roles across product lifecycle management, FDA submissions, and quality compliance. Openings range from associate-level positions for recent life sciences graduates to senior roles overseeing global regulatory strategy. Find a role that fits below and apply directly.
Find JobsOverview
Showing 5 of 20+ Regulatory Affairs Analyst jobs
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 122,000 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.
The Opportunity
We are recruiting for a Senior Regulatory Affairs Specialist to join our team on-site in New Brighton, MN. This new team member will provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions as well as assist in identifying data needed, obtaining this data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation, with a primary focus on post-market change management.
What You’ll Work On
- Assist in SOP development and review. Provide regulatory input to product lifecycle planning. Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions. Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
- Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval. Determine trade issues to anticipate regulatory obstacles. Determine and communicate submission and approval requirements. Participate in risk-benefit analysis for regulatory compliance.
- Monitor impact of changing regulations on submission strategies. Monitor applications under regulatory review. Monitor and submit applicable reports to regulatory authorities. Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies. Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
- Maintain annual licenses, registrations, listings and patent information. Obtain US and EU post-market change approvals/clearances while coordinating necessary submissions and approvals with international affiliates to maintain compliance with product postmarketing approval requirements.
- Strong technical writing for regulatory agency audience, able to independently draft US and EU post-market change submissions and deficiency responses.
- Submit and review change controls to determine the level of change and consequent submission requirements. Analyze the input of cumulative product changes to current product submissions.
- Contribute to the development and functioning of the crisis/ issue management program. Ensure product safety issues and product-associated events are reported to regulatory agencies. Provide regulatory input for product recalls and recall communications Job specific responsibilities may include (choose applicable areas and expand as appropriate).
- Medical writing, Advertising and promotion, Labeling, Controlled substances (e.g. DEA), Restricted substances (e.g. REACH), Compendial / standards, Import / export, Country specific regulatory support, including animal tissue documentation.
Required Qualifications
- Bachelor’s Degree or an equivalent combination of education and experience
- 3-4 years’ experience in a regulated industry (e.g., medical products, nutritionals).
- 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
- Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Communicate effectively verbally and in writing.
- Ability to work in a highly matrixed and geographically diverse environment.
- Has broad knowledge of various technical alternatives and their potential impact on the business.
- Exercise good and ethical judgment within policy and regulations.
- Use in-depth knowledge of business functions and cross group dependencies/ relationships.
- Define regulatory strategy with supervision.
- Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues.
Preferred Qualifications
- Master’s Degree in Regulatory Affairs preferred and may be used in lieu of direct regulatory experience.
- 5+ years’ experience in Medical Device industry
- 3-5 years of regulatory experience.
- Think analytically with good problem-solving skills.
- 510(k), PMA, or other international regulatory submission experience.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
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.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted.
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 122,000 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.
The Opportunity
We are recruiting for a Senior Regulatory Affairs Specialist to join our team on-site in New Brighton, MN. This new team member will provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions as well as assist in identifying data needed, obtaining this data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation, with a primary focus on post-market change management.
What You’ll Work On
- Assist in SOP development and review. Provide regulatory input to product lifecycle planning. Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions. Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
- Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval. Determine trade issues to anticipate regulatory obstacles. Determine and communicate submission and approval requirements. Participate in risk-benefit analysis for regulatory compliance.
- Monitor impact of changing regulations on submission strategies. Monitor applications under regulatory review. Monitor and submit applicable reports to regulatory authorities. Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies. Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
- Maintain annual licenses, registrations, listings and patent information. Obtain US and EU post-market change approvals/clearances while coordinating necessary submissions and approvals with international affiliates to maintain compliance with product postmarketing approval requirements.
- Strong technical writing for regulatory agency audience, able to independently draft US and EU post-market change submissions and deficiency responses.
- Submit and review change controls to determine the level of change and consequent submission requirements. Analyze the input of cumulative product changes to current product submissions.
- Contribute to the development and functioning of the crisis/ issue management program. Ensure product safety issues and product-associated events are reported to regulatory agencies. Provide regulatory input for product recalls and recall communications Job specific responsibilities may include (choose applicable areas and expand as appropriate).
- Medical writing, Advertising and promotion, Labeling, Controlled substances (e.g. DEA), Restricted substances (e.g. REACH), Compendial / standards, Import / export, Country specific regulatory support, including animal tissue documentation.
Required Qualifications
- Bachelor’s Degree or an equivalent combination of education and experience
- 3-4 years’ experience in a regulated industry (e.g., medical products, nutritionals).
- 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
- Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Communicate effectively verbally and in writing.
- Ability to work in a highly matrixed and geographically diverse environment.
- Has broad knowledge of various technical alternatives and their potential impact on the business.
- Exercise good and ethical judgment within policy and regulations.
- Use in-depth knowledge of business functions and cross group dependencies/ relationships.
- Define regulatory strategy with supervision.
- Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues.
Preferred Qualifications
- Master’s Degree in Regulatory Affairs preferred and may be used in lieu of direct regulatory experience.
- 5+ years’ experience in Medical Device industry
- 3-5 years of regulatory experience.
- Think analytically with good problem-solving skills.
- 510(k), PMA, or other international regulatory submission experience.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
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.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted.
See All 20 Regulatory Affairs Analyst Jobs in Minnesota
Find roles in Minnesota that match your experience and apply in just a few clicks.
Find JobsRegulatory Affairs Analyst Jobs by City in Minnesota
Where Minnesota roles are concentrated, by current openings.
Regulatory Affairs Analyst Job Market in Minnesota
A snapshot from current Minnesota openings, updated as new roles post.
Who's Hiring
Top Industries Hiring
- Medical Devices
- Consulting & Professional Services
What Minnesota Employers Look For
The qualifications that appear most often in regulatory affairs analyst jobs across Minnesota.
- Bachelor's degree in life sciences, chemistry, engineering, or a closely related field
- Experience with FDA regulatory submissions including 510(k), PMA, or NDA filings
- Knowledge of ISO 13485, 21 CFR Part 820, or relevant medical device quality standards
- Proficiency with regulatory information management systems such as Veeva or MasterControl
- Strong technical writing skills for preparing regulatory documents and dossiers
- RAC certification from the Regulatory Affairs Professionals Society preferred for senior roles
Regulatory Affairs Analyst Jobs in Minnesota: Frequently Asked Questions
How do you become a regulatory affairs analyst in Minnesota?
Most regulatory affairs analyst roles in Minnesota require a bachelor's degree in a life sciences field such as biology, chemistry, biomedical engineering, or pharmacy. Minnesota does not issue a state-specific license for this role, so credentials like the RAC designation from the Regulatory Affairs Professionals Society carry significant weight with employers. Hiring managers in the Twin Cities medical device corridor look for familiarity with FDA frameworks and quality systems alongside the degree.
Which companies hire regulatory affairs analysts in Minnesota?
Companies currently hiring regulatory affairs analysts in Minnesota include Abbott, Boston Scientific, and Bracco Medical Technologies, per current listings on Migrate Mate as of November 2026. Minnesota's concentration of medical device and food manufacturing headquarters means demand is unusually consistent compared with most states.
Which Minnesota cities have the most regulatory affairs analyst jobs?
The cities with the most regulatory affairs analyst openings in Minnesota are Minneapolis, Eden Prairie, and Rochester. The Twin Cities account for the large majority of postings because major medical device and food company headquarters are based there, while Rochester draws openings tied to its health sciences and medical research ecosystem.
Are there remote regulatory affairs analyst jobs in Minnesota?
Yes, and more than most fields. Regulatory affairs work is largely documentation, review, and submission-based, making it well suited to remote arrangements. About 50% of regulatory affairs analyst openings tied to Minnesota are remote or hybrid as of November 2026, reflecting the desk-driven nature of the role. Submission coordination and regulatory writing positions tend to offer the most remote flexibility, while roles requiring lab or manufacturing floor oversight are more likely to be on-site.
How can I get hired as a regulatory affairs analyst in Minnesota with little or no experience?
The most realistic entry path is a quality assurance associate or regulatory affairs coordinator role at one of Minnesota's medical device or food companies, where you build hands-on FDA and ISO documentation experience. Medtronic and Boston Scientific both run structured early-career and rotational programs in the Twin Cities that include regulatory exposure. A biology or chemistry degree combined with a RAC exam attempt or a graduate certificate in regulatory science from the University of Minnesota signals commitment to hiring managers reviewing entry-level applications.
Where can I find and apply to regulatory affairs analyst jobs in Minnesota?
You can find and apply to regulatory affairs analyst jobs in Minnesota on Migrate Mate, which lists current Minnesota openings updated regularly. Find roles that fit your experience and apply directly to the employers posting them.
See All 20 Regulatory Affairs Analyst Jobs in Minnesota
Find roles in Minnesota that match your experience and apply in just a few clicks.
Find Jobs