H-1B Visa Senior Regulatory Affairs Specialist Jobs
Senior Regulatory Affairs Specialists qualify for H-1B 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 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 32+ 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.
Senior Regulatory Affairs Specialist jobs are hiring across the US. Find yours.
Find Senior Regulatory Affairs Specialist JobsSenior Regulatory Affairs Specialist H-1B Visa: 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.
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