Regulatory Affairs Specialist Jobs in Minnesota
Regulatory affairs specialist jobs in Minnesota are consistently active, concentrated in the state's robust medical device, pharmaceutical, and food manufacturing sectors, with openings at every level from associate specialist to senior regulatory lead. Most hiring is centered in Minneapolis-St. Paul and its surrounding suburbs, with additional activity in Rochester and Arden Hills, where anchors like Medtronic, 3M, and Abbott Laboratories maintain large regulatory and quality teams. The most in-demand specialties are FDA submissions, ISO 13485 compliance, and drug and device labeling. Scan the live roles below and apply to whichever ones fit.
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Showing 5 of 20+ Regulatory Affairs Specialist 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 Specialist Jobs in Minnesota
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Find JobsRegulatory Affairs Specialist Jobs by City in Minnesota
Where Minnesota roles are concentrated, by current openings.
Regulatory Affairs Specialist 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 specialist jobs across Minnesota.
- Bachelor's degree in life sciences, chemistry, engineering, or a related technical field
- Working knowledge of FDA regulations for medical devices, pharmaceuticals, or food products
- Experience preparing and submitting regulatory filings such as 510(k), PMA, or NDA packages
- Familiarity with ISO 13485 quality management standards and applicable Minnesota industry requirements
- Strong technical writing skills for preparing SOPs, labeling, and regulatory correspondence
- Regulatory Affairs Certification (RAC) from RAPS preferred for mid-level and senior Minnesota openings
Regulatory Affairs Specialist Jobs in Minnesota: Frequently Asked Questions
How do you become a regulatory affairs specialist in Minnesota?
Most regulatory affairs specialists in Minnesota start with a bachelor's degree in a life science, engineering, or health-related field, followed by experience in a regulated industry such as medical devices, pharmaceuticals, or food manufacturing. Minnesota does not issue a state-specific license for the role, but the Regulatory Affairs Certification (RAC) offered by the Regulatory Affairs Professionals Society is the most recognized credential among Minnesota employers and strengthens candidacy considerably at the mid-career level.
How much do regulatory affairs specialists make in Minnesota?
Regulatory affairs specialists 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 companies hire regulatory affairs specialists in Minnesota?
Employers hiring regulatory affairs specialists in Minnesota right now include Abbott, Boston Scientific, and Bracco Medical Technologies, based on current listings on Migrate Mate as of November 2026. Minnesota's density of global medical device and life sciences headquarters makes it one of the more consistent markets in the country for this role.
Which Minnesota cities have the most regulatory affairs specialist jobs?
Minneapolis, Eden Prairie, and Rochester have the most regulatory affairs specialist openings in Minnesota. The Minneapolis-St. Paul metro drives the bulk of demand because it is home to the global headquarters and major campuses of the state's largest medical device and health sciences companies, while Rochester benefits from the presence of major healthcare systems and biomedical research operations, and suburban corridors like Arden Hills and Fridley host significant device and pharmaceutical manufacturing sites.
Are there remote regulatory affairs specialist jobs in Minnesota?
Yes, and more than most technical roles, since regulatory affairs work is largely document- and submission-driven rather than hands-on. About 50% of regulatory affairs specialist openings tied to Minnesota are remote or hybrid as of November 2026, reflecting the desk-based nature of the work. Roles focused on FDA submissions, labeling review, and regulatory strategy tend to offer the most remote flexibility, while positions requiring lab access or direct manufacturing floor support are more likely to require on-site presence.
How can I get hired as a regulatory affairs specialist in Minnesota with little or no experience?
The most realistic entry path is a quality assurance associate or regulatory affairs coordinator role, which large Minnesota medical device employers commonly use as feeder positions into full specialist tracks. Companies like Medtronic, Boston Scientific, and Abbott operate rotational programs and structured associate pipelines for candidates with relevant life sciences degrees. Pursuing the RAC-In-Training designation through RAPS while in an entry role signals commitment to Minnesota hiring managers. Adjacent experience in quality control, clinical documentation, or technical writing at a regulated Minnesota employer also transfers well into a first regulatory affairs position.
Where can I find and apply to regulatory affairs specialist jobs in Minnesota?
You can find and apply to regulatory affairs specialist jobs in Minnesota on Migrate Mate, which lists current Minnesota openings. Search the listings, find roles that match your background and preferences, and apply directly to the ones that fit.
See All 20 Regulatory Affairs Specialist Jobs in Minnesota
Find roles in Minnesota that match your experience and apply in just a few clicks.
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