Senior Regulatory Affairs Specialist Green Card 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 JobsWhy join Stryker?
Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
Job description
We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more: US Stryker employee benefits.
Senior Regulatory Affairs Specialist – Labeling
Irvine, CA
In this role, you will help shape and maintain accurate, compliant medical device labeling across global markets, supporting products from development through the post-market lifecycle. If you are energized by global impact, cross-functional collaboration, and meaningful work in a regulated environment, this role offers an opportunity to grow while making a difference.
What You Will Do
- Evaluate medical device labeling to ensure compliance with global regulatory requirements and standards, supporting market access and patient safety.
- Prepare, review, and maintain labeling content across the full product lifecycle for multiple global markets.
- Support new product development by contributing labeling elements to regulatory submissions for global registrations.
- Maintain sustaining registrations through labeling updates, renewals, and post-market changes.
- Analyze emerging regulatory intelligence related to labeling and assess impacts to current and future products.
- Provide regulatory guidance on global labeling requirements to cross-functional partners, enabling timely and compliant decisions.
- Support global regulatory submissions by preparing and submitting documentation in alignment with applicable regulatory requirements.
- Participate in internal and external audits and contribute to the development and improvement of regulatory procedures and labeling processes.
What You Will Need
Required Qualifications
- Bachelor’s degree in Science, Engineering, or a related discipline.
- 2+ years of experience in a Regulatory Affairs role within an FDA-regulated or similarly regulated industry.
Preferred Qualifications
- Experience preparing medical device labeling aligned with global standards and regulations (e.g., ISO and U.S. regulations).
- Experience supporting Class I, Class II, and/or Class III medical devices.
- Experience supporting U.S. and international regulatory submissions.
- Prior interaction with regulatory agencies.
- RAC certification and/or an advanced degree in Regulatory Affairs or a related field.
Compensation
- $95,800 - $159,600 USD Annual
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
Why join Stryker?
Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
Job description
We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more: US Stryker employee benefits.
Senior Regulatory Affairs Specialist – Labeling
Irvine, CA
In this role, you will help shape and maintain accurate, compliant medical device labeling across global markets, supporting products from development through the post-market lifecycle. If you are energized by global impact, cross-functional collaboration, and meaningful work in a regulated environment, this role offers an opportunity to grow while making a difference.
What You Will Do
- Evaluate medical device labeling to ensure compliance with global regulatory requirements and standards, supporting market access and patient safety.
- Prepare, review, and maintain labeling content across the full product lifecycle for multiple global markets.
- Support new product development by contributing labeling elements to regulatory submissions for global registrations.
- Maintain sustaining registrations through labeling updates, renewals, and post-market changes.
- Analyze emerging regulatory intelligence related to labeling and assess impacts to current and future products.
- Provide regulatory guidance on global labeling requirements to cross-functional partners, enabling timely and compliant decisions.
- Support global regulatory submissions by preparing and submitting documentation in alignment with applicable regulatory requirements.
- Participate in internal and external audits and contribute to the development and improvement of regulatory procedures and labeling processes.
What You Will Need
Required Qualifications
- Bachelor’s degree in Science, Engineering, or a related discipline.
- 2+ years of experience in a Regulatory Affairs role within an FDA-regulated or similarly regulated industry.
Preferred Qualifications
- Experience preparing medical device labeling aligned with global standards and regulations (e.g., ISO and U.S. regulations).
- Experience supporting Class I, Class II, and/or Class III medical devices.
- Experience supporting U.S. and international regulatory submissions.
- Prior interaction with regulatory agencies.
- RAC certification and/or an advanced degree in Regulatory Affairs or a related field.
Compensation
- $95,800 - $159,600 USD Annual
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
See all 35+ Senior Regulatory Affairs Specialist jobs
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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.
Senior Regulatory Affairs Specialist jobs are hiring across the US. Find yours.
Find Senior Regulatory Affairs Specialist JobsSenior Regulatory Affairs Specialist Green Card Sponsorship: 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.
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