Green Card Senior Regulatory Affairs Specialist Jobs
Senior Regulatory Affairs Specialist roles qualify for EB-2 or EB-3 green card sponsorship through the PERM labor certification process, which requires your employer to document that no qualified U.S. worker is available. Pharmaceutical, biotech, and medical device companies regularly file I-140 petitions for these roles given the specialized regulatory science background required.
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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.
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Get Access To All JobsTips for Finding Green Card Sponsorship as a Senior Regulatory Affairs Specialist
Align your credentials to EB-2 requirements
A master's degree in regulatory affairs, pharmaceutical sciences, or a related life sciences field positions you for EB-2 classification. If your degree is from outside the U.S., get a credential evaluation completed before applying so employers can confirm your eligibility upfront.
Target employers with active PERM filing history
Pharmaceutical, biotech, and medical device companies with dedicated regulatory departments file PERM applications regularly for this role. Filter your search by companies that have sponsored regulatory affairs positions before, not just those with general sponsorship policies.
Use Migrate Mate to find sponsoring employers
Search Migrate Mate to identify companies actively sponsoring Senior Regulatory Affairs Specialist roles for green cards. The platform surfaces employers with verified EB-2 and EB-3 filing history, saving you from applying to companies that only sponsor H-1B visas.
Document your regulatory specialization before PERM starts
PERM requires your employer to define a job description tight enough to justify why standard recruitment did not yield a qualified U.S. applicant. Compile records of your FDA submission experience, therapeutic area expertise, or CTD dossier work before the process begins.
Negotiate sponsorship terms before accepting an offer
Confirm whether the employer covers PERM attorney fees and I-140 filing costs, and ask about their policy if you change roles internally before your green card is approved. These terms are far easier to resolve before you sign than after.
Understand EB-2 versus EB-3 category implications for your timeline
If your country of birth has a priority date backlog, your employer's choice of EB-2 versus EB-3 affects how long you wait for a visa number to become available. Confirm which category fits your qualifications and check the USCIS Visa Bulletin before your I-140 is filed.
Green Card Senior Regulatory Affairs Specialist: Frequently Asked Questions
Does a Senior Regulatory Affairs Specialist role qualify for EB-2 or EB-3 sponsorship?
Both categories apply, depending on your qualifications. EB-2 covers candidates with an advanced degree or the equivalent in regulatory affairs, pharmaceutical sciences, or a related field. EB-3 covers professionals with a bachelor's degree. Most employers in pharma and medical devices file under EB-2 for senior-level regulatory roles because the position typically requires graduate-level education or substantial specialized experience.
How does green card sponsorship differ from H-1B for this role?
Green card sponsorship through PERM leads to permanent residency, while H-1B is a temporary status requiring renewal every three years. PERM has no annual lottery, so there's no random selection risk. The tradeoff is timeline: PERM labor certification, I-140 approval, and adjustment of status can take two to four years or longer depending on your country of birth. H-1B can be obtained faster but offers no path to permanency on its own.
What does the PERM labor certification process look like for regulatory affairs roles?
Your employer files the PERM application with DOL after completing a mandatory recruitment period, typically 30 to 60 days, to demonstrate no qualified U.S. worker applied. For Senior Regulatory Affairs Specialist positions, the job description must specify the regulatory requirements, such as FDA submission experience or ICH guideline knowledge, that justify the role's qualifications. DOL then reviews the application, which can take six months to over a year.
Can I switch employers after my green card sponsorship begins?
Once your I-140 petition is approved and your priority date is more than 180 days old, you may port your green card sponsorship to a new employer in a same or similar regulatory affairs role under AC21 portability rules. Porting requires the new role to be substantially similar in duties, responsibilities, and required qualifications. You should document the similarity carefully with help from an immigration attorney before changing jobs.
Where can I find Senior Regulatory Affairs Specialist jobs with green card sponsorship?
Migrate Mate is built specifically for foreign professionals searching for employment-based green card and visa-sponsored roles. You can filter by job title and sponsorship type to find companies actively filing PERM and I-140 petitions for regulatory affairs positions, rather than sifting through listings where sponsorship availability is unclear or limited to H-1B only.