H-1B Visa Senior Regulatory Affairs Specialist Jobs
Senior Regulatory Affairs Specialists qualify for H-1B visa sponsorship as a specialty occupation requiring a bachelor's degree or higher in a directly related scientific or technical field. Pharmaceutical, biotech, and medical device companies are the most consistent H-1B filers for this role, with LCA filings concentrated in New Jersey, California, and Massachusetts.
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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.
ABOUT ABBOTT
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
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.
ABOUT LINGO
Meet Lingo, a new biosensing technology that provides users a window into their body. Lingo tracks key biomarkers – such as glucose, ketones, and lactate – to help people make better decisions about their health and nutrition. Biowearable technology will digitize, decentralize and democratize healthcare, enabling consumers to take control of their own health.
THE OPPORTUNITY
Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare.
As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize products in the US. In this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines. This is an exciting on-site opportunity at Lingo in Alameda, CA.
WHAT YOU’LL WORK ON
- Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class II software medical devices.
- Assess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidance.
- Review and analyze labeling, advertising and promotional materials while working with Marketing teams to provide regulatory strategy and compliance input.
- Assist with promotional content development and review for compliance before distribution.
- Lead Regulatory Affairs Ad & Promo SOP development and review.
- Prepares robust regulatory applications/submissions to regulatory authorities.
- Assist in SOP development and review in support of "next-gen" product offerings.
- Evaluate proposed design, labeling, and distribution changes for regulatory impact and implement any required regulatory action.
- Utilize technical regulatory skills to propose strategies on complex issues.
- Ensure compliance with product post marketing requirements.
- Review product labeling to ensure compliance with relevant regulatory requirements.
- Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees.
- Establishes and cultivates an extensive network of support to facilitate completion of assignments.
- Influences middle management on technical or business solutions.
REQUIRED QUALIFICATIONS:
- Bachelor's Degree; preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc.
- Minimum 2 yrs. regulatory experience and or 2 years relevant industrial experience typically with a quality; product-development/support; scientific affairs function.
PREFERRED QUALIFICATIONS:
- Advanced degree in Engineering, Sciences, or related discipline.
- Previous experience with 510(k)/PMA submissions or class I / II exempt software devices.
- Experience with software medical devices.
- 4-6 years’ experience in a regulated industry. Regulatory area is preferred but may consider quality assurance, software or systems research and development, or related area.
- Ability to work effectively on cross-functional teams.
- Must be able to juggle multiple and competing priorities.
- Ability to identify and solve problems and work independently with little oversight.
- Strong written, verbal, presentation, and organizational skills.
- Working knowledge of FDA QSR.
- Has a sound knowledge of a variety of alternatives and their impact on the business.
COMPENSATION
- The base pay for this position is $90,000.00 – $180,000.00. 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.
ABOUT ABBOTT
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
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.
ABOUT LINGO
Meet Lingo, a new biosensing technology that provides users a window into their body. Lingo tracks key biomarkers – such as glucose, ketones, and lactate – to help people make better decisions about their health and nutrition. Biowearable technology will digitize, decentralize and democratize healthcare, enabling consumers to take control of their own health.
THE OPPORTUNITY
Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare.
As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize products in the US. In this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines. This is an exciting on-site opportunity at Lingo in Alameda, CA.
WHAT YOU’LL WORK ON
- Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class II software medical devices.
- Assess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidance.
- Review and analyze labeling, advertising and promotional materials while working with Marketing teams to provide regulatory strategy and compliance input.
- Assist with promotional content development and review for compliance before distribution.
- Lead Regulatory Affairs Ad & Promo SOP development and review.
- Prepares robust regulatory applications/submissions to regulatory authorities.
- Assist in SOP development and review in support of "next-gen" product offerings.
- Evaluate proposed design, labeling, and distribution changes for regulatory impact and implement any required regulatory action.
- Utilize technical regulatory skills to propose strategies on complex issues.
- Ensure compliance with product post marketing requirements.
- Review product labeling to ensure compliance with relevant regulatory requirements.
- Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees.
- Establishes and cultivates an extensive network of support to facilitate completion of assignments.
- Influences middle management on technical or business solutions.
REQUIRED QUALIFICATIONS:
- Bachelor's Degree; preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc.
- Minimum 2 yrs. regulatory experience and or 2 years relevant industrial experience typically with a quality; product-development/support; scientific affairs function.
PREFERRED QUALIFICATIONS:
- Advanced degree in Engineering, Sciences, or related discipline.
- Previous experience with 510(k)/PMA submissions or class I / II exempt software devices.
- Experience with software medical devices.
- 4-6 years’ experience in a regulated industry. Regulatory area is preferred but may consider quality assurance, software or systems research and development, or related area.
- Ability to work effectively on cross-functional teams.
- Must be able to juggle multiple and competing priorities.
- Ability to identify and solve problems and work independently with little oversight.
- Strong written, verbal, presentation, and organizational skills.
- Working knowledge of FDA QSR.
- Has a sound knowledge of a variety of alternatives and their impact on the business.
COMPENSATION
- The base pay for this position is $90,000.00 – $180,000.00. 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 H-1B Visa Senior Regulatory Affairs Specialist Jobs
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Senior Regulatory Affairs Specialist
Align your degree to SOC codes
USCIS evaluates specialty occupation based on whether your degree field directly relates to the role. Check the O*NET profile for Regulatory Affairs Specialists to confirm which degree fields map cleanly to this SOC code before applying.
Target LCA-active pharmaceutical employers
Search Migrate Mate to filter for employers with verified LCA filings for Regulatory Affairs roles. Companies actively filing Labor Condition Applications have already cleared the DOL certification step and are structurally set up to sponsor.
Document your regulatory submissions portfolio
Compile a record of FDA submissions, dossiers, or health authority interactions you've led. Employers use this documentation to build the specialty occupation justification in your I-129 petition, so specificity about submission types and therapeutic areas strengthens the filing.
Clarify the prevailing wage level early
Use the OFLC Wage Search to look up the prevailing wage for your target job title, SOC code, and metro area before negotiating an offer. Your offered salary must meet or exceed the DOL wage level the employer certifies on the LCA.
Confirm cap-subject status before your H-1B start date
Regulatory roles at biotech startups and most pharma companies are cap-subject, meaning you'll need to register in the annual lottery. Roles at nonprofit research hospitals or FDA-funded academic medical centers may qualify as cap-exempt, which changes your timeline entirely.
Address degree equivalency for three-year credentials
If you hold a three-year bachelor's degree, your employer's attorney will need a credential evaluation and possibly a professional opinion letter to establish equivalency to a U.S. four-year degree. Request this evaluation early so it's ready when the I-129 is filed.
H-1B Visa Senior Regulatory Affairs Specialist: Frequently Asked Questions
Does a Senior Regulatory Affairs Specialist role qualify as a specialty occupation for H-1B purposes?
Yes. USCIS treats Regulatory Affairs Specialist positions as specialty occupations because they typically require a bachelor's degree or higher in a directly related field such as life sciences, pharmacy, chemistry, or biomedical engineering. Employers strengthen the petition by documenting that the specific role requires this degree, not just that candidates often hold one.
Which industries sponsor H-1B visas most consistently for this role?
Pharmaceutical manufacturers, biotechnology companies, and medical device firms account for the large majority of H-1B LCA filings for Regulatory Affairs roles. Contract research organizations and clinical-stage startups also file regularly. You can browse employers with verified LCA filing history for this occupation on Migrate Mate before you apply.
How does the H-1B lottery affect my job search timeline as a regulatory professional?
Cap-subject H-1B registrations are submitted in March for an October 1 start date. If you're currently on OPT or STEM OPT, you need an employer to register you during that window. Roles at qualifying nonprofit research institutions or government research entities may be cap-exempt, allowing filing year-round without a lottery slot.
What happens to my H-1B status if I move from one regulatory role to another employer?
H-1B portability under AC21 lets you start with a new employer once you've filed a new I-129 petition, as long as your original petition has been approved and you've been in valid H-1B status for at least 180 days. Your new employer must file before your current status expires, and the new role must remain in the same or a substantially similar specialty occupation.
Can my employer sponsor me for a green card while I'm on H-1B in a regulatory affairs role?
Yes. Most employer-sponsored green card paths for Regulatory Affairs Specialists go through the PERM labor certification process, which requires the employer to test the labor market before filing. EB-2 or EB-3 classification applies depending on the degree requirement attached to the role. You can remain in H-1B status throughout the PERM and I-140 stages.