Regulatory Affairs Jobs in USA with Visa Sponsorship
Regulatory affairs is a strong field for visa sponsorship, particularly through H-1B visas, because the role clearly requires specialized knowledge in science, law, or a related field. Pharmaceutical companies, biotech firms, and medical device manufacturers regularly sponsor regulatory affairs professionals. This is one of the more straightforward specialty occupation arguments you can make, and salaries in this field typically exceed H-1B visa wage requirements comfortably. For detailed occupation requirements, see the O*NET profile.
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Get Access To All JobsINTRODUCTION
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.
Senior Regulatory Affairs Specialist
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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our Itasca or Chicago, IL (Willis Towers) location in the Abbott Molecular Division. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.
As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to 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. This role is part of the on-market regulatory team and includes responsibility for performing regulatory impact assessments for changes related to marketed products. The individual may assist in identifying data needed, obtaining 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.
What You’ll Work On
- Interpret and apply regulatory requirements.
- Perform regulatory impact assessments to evaluate changes for on-market products.
- Compile, prepare, review, and submit regulatory submissions to authorities.
- Regulatory history, guidelines, policies, standards, practices, requirements, and precedents.
- Regulatory agency structure, processes, and key personnel.
- Principles and requirements of applicable product laws.
- Submission/registration types and requirements.
- Principles and requirements of promotion, advertising, and labeling.
- Domestic and international regulatory guidelines, policies, and regulations.
- Ethical guidelines of the regulatory profession, clinical research, and regulatory process.
Required Qualifications
- Bachelor’s degree (or equivalent); bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
- Regulatory experience or relevant industrial experience typically with a quality; product development/support, scientific affairs function.
Preferred Qualifications
- Two to Three years of experience in regulatory preferred.
- Three to four years’ experience in a regulated industry (e.g., medical products, nutrition).
- Masters degree in Regulatory Affairs may be used in lieu of direct regulatory experience.
Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next year.
COMPENSATION
- 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.
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.
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.
Senior Regulatory Affairs Specialist
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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our Itasca or Chicago, IL (Willis Towers) location in the Abbott Molecular Division. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.
As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to 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. This role is part of the on-market regulatory team and includes responsibility for performing regulatory impact assessments for changes related to marketed products. The individual may assist in identifying data needed, obtaining 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.
What You’ll Work On
- Interpret and apply regulatory requirements.
- Perform regulatory impact assessments to evaluate changes for on-market products.
- Compile, prepare, review, and submit regulatory submissions to authorities.
- Regulatory history, guidelines, policies, standards, practices, requirements, and precedents.
- Regulatory agency structure, processes, and key personnel.
- Principles and requirements of applicable product laws.
- Submission/registration types and requirements.
- Principles and requirements of promotion, advertising, and labeling.
- Domestic and international regulatory guidelines, policies, and regulations.
- Ethical guidelines of the regulatory profession, clinical research, and regulatory process.
Required Qualifications
- Bachelor’s degree (or equivalent); bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
- Regulatory experience or relevant industrial experience typically with a quality; product development/support, scientific affairs function.
Preferred Qualifications
- Two to Three years of experience in regulatory preferred.
- Three to four years’ experience in a regulated industry (e.g., medical products, nutrition).
- Masters degree in Regulatory Affairs may be used in lieu of direct regulatory experience.
Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next year.
COMPENSATION
- 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.
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.
See all 364+ Regulatory Affairs Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Regulatory Affairs roles.
Get Access To All JobsTips for Finding Regulatory Affairs Jobs
Earn the RAC credential from RAPS
The Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society is the gold standard in the field. Available in three specializations - drugs, devices, and biologics - RAC demonstrates comprehensive knowledge of U.S. and international regulatory frameworks. Holding this credential strengthens both your job competitiveness and the employer's H-1B specialty occupation argument.
Target the Boston-Cambridge and San Francisco biotech hubs
The largest concentrations of pharma and biotech companies are in the Boston-Cambridge corridor and the San Francisco Bay Area, including South San Francisco. Companies in these hubs compete intensely for regulatory affairs talent and are experienced with H-1B sponsorship. The New Jersey pharmaceutical corridor around Princeton and New Brunswick is another major cluster.
Specialize in biologics or combination device regulation
Regulatory professionals with expertise in biologics (BLA submissions), biosimilars (351(k) pathway), or combination products face less competition than those in traditional small-molecule drug regulation. The FDA's regulatory framework for biologics and combination devices is complex and evolving, creating sustained demand for specialists. This specialization can differentiate you from a larger pool of general regulatory affairs candidates.
Leverage international regulatory experience as a global asset
Pharmaceutical companies filing regulatory submissions across multiple markets need professionals who understand EMA, PMDA, TGA, Health Canada, and other regulatory agencies alongside the FDA. If you have experience preparing submissions for non-U.S. regulatory bodies, position this as a strategic asset for global regulatory strategy. Companies pursuing simultaneous multi-market approvals value this cross-border expertise.
Consider contract regulatory affairs positions as an entry strategy
Contract research organizations (CROs) like IQVIA, Parexel, and PPD, as well as regulatory affairs staffing firms, place professionals in pharmaceutical and device companies for specific projects. These positions provide U.S. regulatory experience and industry connections. Some CROs sponsor H-1B visas directly, and strong performance on contract assignments can lead to direct-hire offers from the host company.
Frequently Asked Questions
Do pharmaceutical and biotech companies sponsor regulatory affairs professionals?
Yes, regulatory affairs is a specialized field with strong H-1B visa sponsorship demand across pharma, biotech, and medical device companies. Positions typically require a bachelor's or master's degree in life sciences, pharmacy, or a related field, plus knowledge of FDA regulations. Companies like Pfizer, Johnson and Johnson, Roche, AbbVie, Merck, and Medtronic regularly sponsor regulatory affairs specialists and managers.
What makes regulatory affairs a strong field for visa sponsorship?
Regulatory affairs professionals possess specialized knowledge of FDA submission processes (510(k), PMA, NDA, BLA, ANDA), international regulatory frameworks, and clinical development regulations. This expertise is difficult to replace and clearly meets the H-1B specialty occupation standard. The field has a relatively small talent pool compared to demand, particularly for professionals experienced with complex biological products or combination devices.
What degree is needed for regulatory affairs visa sponsorship?
A bachelor's degree in a life science (biology, chemistry, pharmacy, biomedical engineering) is the minimum, and many roles prefer or require a master's degree. Some universities offer specialized Master of Science in Regulatory Affairs or Regulatory Science programs - Johns Hopkins, Northeastern, and University of Southern California are among them. A Regulatory Affairs Certification (RAC) from RAPS further strengthens your credentials.
How to find Regulatory Affairs jobs with visa sponsorship?
To find Regulatory Affairs jobs with visa sponsorship, use Migrate Mate, which specializes in connecting international professionals with sponsoring employers. Focus on pharmaceutical companies, medical device manufacturers, biotechnology firms, and healthcare organizations that frequently sponsor H-1B, L-1 visa, and other work visas for regulatory professionals. These industries regularly need qualified candidates to navigate complex compliance requirements and often sponsor international talent.
Can regulatory affairs experience from outside the U.S. count toward a visa petition?
Yes, experience with international regulatory agencies - EMA (Europe), PMDA (Japan), TGA (Australia), Health Canada, or NMPA (China) - is valuable and can support your H-1B petition. Many pharmaceutical companies need professionals who understand both FDA and international regulatory pathways for global submissions. This cross-border expertise makes you more valuable to multinational employers.
What is the prevailing wage requirement for sponsored Regulatory Affairs jobs?
When a U.S. employer sponsors a foreign worker for a work visa, they are legally required to pay at least the "prevailing wage" — the average wage paid to workers in the same occupation, in the same geographic area, with similar experience. This is set by the Department of Labor to prevent employers from hiring foreign workers at below-market rates. The prevailing wage varies significantly by role, location, and experience level — for example, a regulatory affairs in California will have a different prevailing wage than the same role in a smaller state. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search.