H-1B Visa Regulatory Affairs Specialist Jobs
Regulatory Affairs Specialists qualify for H-1B visa sponsorship because the role meets the specialty occupation standard: a bachelor's degree or higher in life sciences, pharmacy, or a related field is typically required. Pharma, biotech, and medical device companies are among the most active H-1B filers for this title.
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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.
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
In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
THE OPPORTUNITY
As an individual contributor, the International Regulatory Affairs Specialist I performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. This new team member will support necessary regulatory activities required for product market entry. This individual will work on-site at our Plymouth, MN location.
WHAT YOU’LL WORK ON
- Assists in the preparation of regulatory applications to achieve departmental and organizational objectives, specifically for Asian geographies.
- Provide regulatory input to product lifecycle planning. Monitor regulatory outcomes of initial product concepts and provide input to regulatory management.
- Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes.
- Supports change assessment process for regulatory impact within their region of responsibility (mainly Asia for this position)
- Utilize technical regulatory skills to propose strategies on complex issues. Determine submission and approval requirements. Identify emerging issues.
- Acts as core team member as needed to provide guidance of applicable regulatory guidelines and project regulatory assessments for international geos.
- Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by worldwide regulatory agencies to various international affiliates.
- May interface directly with regulatory agencies.
- Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
- Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with regulations and regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
REQUIRED QUALIFICATIONS
- Bachelor’s Degree or an equivalent combination of education and work experience
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage, manage and/or engage others to accomplish projects.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Strong organizational and follow-up skills, as well as attention to detail and focus towards improving quality.
- Multitasks, prioritizes and meets deadlines in timely manner.
PREFERRED QUALIFICATIONS
- Bachelor’s Degree in a Science/Technical discipline (engineering, life sciences, mathematics).
- Master’s degree
- Experience working in a broader enterprise/cross-division business unit model.
- Experience working in the Medical Device industry.
- Regulatory Affairs Professionals Society Certification is a plus.
- Additional language skills including Chinese, Korean, or other Asian languages.
- Flexibility to work later hours for global meetings.
COMPENSATION
- The base pay for this position is $50,700.00 – $101,300.00. In specific locations, the pay range may vary from the range posted.
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.
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
In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
THE OPPORTUNITY
As an individual contributor, the International Regulatory Affairs Specialist I performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. This new team member will support necessary regulatory activities required for product market entry. This individual will work on-site at our Plymouth, MN location.
WHAT YOU’LL WORK ON
- Assists in the preparation of regulatory applications to achieve departmental and organizational objectives, specifically for Asian geographies.
- Provide regulatory input to product lifecycle planning. Monitor regulatory outcomes of initial product concepts and provide input to regulatory management.
- Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes.
- Supports change assessment process for regulatory impact within their region of responsibility (mainly Asia for this position)
- Utilize technical regulatory skills to propose strategies on complex issues. Determine submission and approval requirements. Identify emerging issues.
- Acts as core team member as needed to provide guidance of applicable regulatory guidelines and project regulatory assessments for international geos.
- Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by worldwide regulatory agencies to various international affiliates.
- May interface directly with regulatory agencies.
- Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
- Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with regulations and regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
REQUIRED QUALIFICATIONS
- Bachelor’s Degree or an equivalent combination of education and work experience
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage, manage and/or engage others to accomplish projects.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Strong organizational and follow-up skills, as well as attention to detail and focus towards improving quality.
- Multitasks, prioritizes and meets deadlines in timely manner.
PREFERRED QUALIFICATIONS
- Bachelor’s Degree in a Science/Technical discipline (engineering, life sciences, mathematics).
- Master’s degree
- Experience working in a broader enterprise/cross-division business unit model.
- Experience working in the Medical Device industry.
- Regulatory Affairs Professionals Society Certification is a plus.
- Additional language skills including Chinese, Korean, or other Asian languages.
- Flexibility to work later hours for global meetings.
COMPENSATION
- The base pay for this position is $50,700.00 – $101,300.00. In specific locations, the pay range may vary from the range posted.
Abbott is an Equal Opportunity Employer, committed to employee diversity.
See all 67+ H-1B Visa Regulatory Affairs Specialist Jobs
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Regulatory Affairs Specialist
Align your degree to the role
USCIS requires a direct relationship between your degree field and the job duties. A degree in pharmacy, biochemistry, or regulatory science strengthens your petition. A business or general science degree may trigger an RFE without supporting documentation.
Target LCA-active employers on Migrate Mate
Search Migrate Mate to identify employers who have filed Labor Condition Applications for Regulatory Affairs Specialist roles. This filters for companies with verified H-1B sponsorship history in your specific occupation, not just general sponsorship willingness.
Verify prevailing wage before accepting an offer
Your offered salary must meet the DOL prevailing wage for your job title, industry, and work location. Run the OFLC Wage Search before negotiating to confirm your offer clears the Level I through Level IV wage tiers for your experience.
Document your regulatory credentials upfront
RAC certification, 21 CFR or ICH guideline experience, and submission history for FDA, EMA, or Health Canada all support the specialty occupation argument. Compile these before outreach so employers can assess petition viability early.
Ask about petition timing during interviews
H-1B cap-subject petitions must be filed by April 1 for an October 1 start. If your OPT or grace period ends before October, confirm whether the employer can file for cap-exempt status or structure your start date around the fiscal year cycle.
Cross-reference your SOC code in O*NET
Regulatory Affairs Specialists are classified under SOC 13-1041 or 19-1099 depending on the employer's job description. Confirming the correct SOC code before filing helps ensure the LCA wage level and job duties are accurately matched to your role.
H-1B Visa Regulatory Affairs Specialist: Frequently Asked Questions
Does a Regulatory Affairs Specialist role qualify as a specialty occupation for H-1B purposes?
Yes, in most cases. USCIS evaluates whether the position normally requires a bachelor's degree or higher in a specific field. Regulatory Affairs roles tied to FDA submissions, drug approval processes, or device compliance typically meet this standard when the job description specifies a degree in pharmacy, life sciences, or a related discipline. Roles framed as generalist compliance positions may face additional scrutiny.
Which industries sponsor H-1B visas most often for Regulatory Affairs Specialists?
Pharmaceutical manufacturers, biotechnology companies, and medical device firms file the highest volume of H-1B LCAs for this occupation. Contract research organizations and regulatory consulting firms also sponsor, though at lower volumes. You can browse verified H-1B sponsoring employers in this field directly on Migrate Mate, filtered by occupation and filing history.
Can I transfer my H-1B to a new employer if I switch Regulatory Affairs roles?
Yes. Under H-1B portability rules, you can start working for a new employer as soon as they file an H-1B transfer petition, without waiting for approval. The new employer must file a new I-129 with an updated LCA reflecting the new job title, duties, and work location. You don't need to restart the cap count, but the specialty occupation and prevailing wage requirements apply again.
Does my regulatory experience in another country count toward the H-1B specialty occupation requirement?
Foreign work experience can substitute for education under the three-for-one equivalency rule: three years of specialized experience may replace one year of a four-year degree. Experience with international regulatory frameworks like ICH guidelines, EMA submissions, or TGA processes is relevant, but USCIS will expect a credential evaluation from a NACES-recognized agency if your degree or experience is from outside the U.S.
What happens to my H-1B status if my employer's regulatory project ends and I'm laid off?
You have a 60-day grace period from your last day of employment to find a new sponsor, change to another visa status, or depart the U.S. During this window, you can't work but you remain in a valid period of authorized stay. Filing an H-1B transfer with a new employer before the grace period ends is the most common path to continuing work authorization without interruption.