H-1B Visa Regulatory Affairs Jobs
Regulatory Affairs roles qualify as H-1B visa specialty occupations because they require at least a bachelor's degree in life sciences, pharmacy, or a related technical field. Employers in pharma, biotech, and medical devices file LCAs with the DOL before sponsoring, and many actively recruit internationally trained RA professionals.
Find H-1B Visa Regulatory Affairs JobsOverview
Showing 5 of 286+ Regulatory Affairs jobs
See all 286+ Regulatory Affairs Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Regulatory Affairs roles.
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.
Stryker is hiring a Staff Regulatory Affairs Specialist in Mahwah, NJ to support new product development for our Joint Replacement implant and instrument portfolio across U.S and international markets. This role focuses on developing regulatory strategies, guiding product development teams, and preparing submissions to achieve market access across U.S. and international markets.
What you will do
- Assess regulatory intelligence and update local, regional, and global regulatory strategies based on evolving requirements
- Evaluate the regulatory environment and provide guidance across product lifecycle phases including development, manufacturing, and commercialization
- Determine product classification, submission requirements, and approval pathways across domestic and international markets
- Prepare and submit regulatory filings in accordance with applicable global regulations and timelines
- Identify regulatory risks and obstacles, propose mitigation strategies, and recommend refinements based on regulatory outcomes
- Provide regulatory guidance on quality, preclinical, and clinical documentation to ensure submission readiness and compliance
- Communicate with regulatory authorities to support submissions, monitor review progress, and respond to agency requests
- Develop or update regulatory procedures and train cross-functional stakeholders to maintain compliance across the organization
What you will need
Required Qualifications
- Bachelor’s degree required. Preferred to be in Engineering, Science, or a related field
- Minimum 4 years of experience in regulatory affairs within a regulated industry
- Experience within the medical device industry
Preferred Qualifications
- Master’s degree in Regulatory Science or related discipline
- Regulatory Affairs Certification (RAC)
- Knowledge of 510(k) and/or CE marking pathways
- Experience preparing and submitting regulatory filings (e.g., FDA, EU, or international submissions)
- Experience supporting product lifecycle regulatory activities (development through post-market)
Posted Date: 06/19/2026
This role will be posted for a minimum of 3 days.
United States of America Pay Ranges:
- Puerto Rico: $77,700 - $129,500 USD Annual
- USN: $95,700 - $159,500 USD Annual
- US5: $100,500 - $167,500 USD Annual
- US10: $105,300 - $175,500 USD Annual
- US15: $110,100 - $183,400 USD Annual
- US20: $114,800 - $191,400 USD Annual
- US30: $124,400 - $207,400 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
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.
Stryker is hiring a Staff Regulatory Affairs Specialist in Mahwah, NJ to support new product development for our Joint Replacement implant and instrument portfolio across U.S and international markets. This role focuses on developing regulatory strategies, guiding product development teams, and preparing submissions to achieve market access across U.S. and international markets.
What you will do
- Assess regulatory intelligence and update local, regional, and global regulatory strategies based on evolving requirements
- Evaluate the regulatory environment and provide guidance across product lifecycle phases including development, manufacturing, and commercialization
- Determine product classification, submission requirements, and approval pathways across domestic and international markets
- Prepare and submit regulatory filings in accordance with applicable global regulations and timelines
- Identify regulatory risks and obstacles, propose mitigation strategies, and recommend refinements based on regulatory outcomes
- Provide regulatory guidance on quality, preclinical, and clinical documentation to ensure submission readiness and compliance
- Communicate with regulatory authorities to support submissions, monitor review progress, and respond to agency requests
- Develop or update regulatory procedures and train cross-functional stakeholders to maintain compliance across the organization
What you will need
Required Qualifications
- Bachelor’s degree required. Preferred to be in Engineering, Science, or a related field
- Minimum 4 years of experience in regulatory affairs within a regulated industry
- Experience within the medical device industry
Preferred Qualifications
- Master’s degree in Regulatory Science or related discipline
- Regulatory Affairs Certification (RAC)
- Knowledge of 510(k) and/or CE marking pathways
- Experience preparing and submitting regulatory filings (e.g., FDA, EU, or international submissions)
- Experience supporting product lifecycle regulatory activities (development through post-market)
Posted Date: 06/19/2026
This role will be posted for a minimum of 3 days.
United States of America Pay Ranges:
- Puerto Rico: $77,700 - $129,500 USD Annual
- USN: $95,700 - $159,500 USD Annual
- US5: $100,500 - $167,500 USD Annual
- US10: $105,300 - $175,500 USD Annual
- US15: $110,100 - $183,400 USD Annual
- US20: $114,800 - $191,400 USD Annual
- US30: $124,400 - $207,400 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
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 286+ H-1B Visa Regulatory Affairs Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Regulatory Affairs Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Regulatory Affairs
Align your degree to FDA submission work
USCIS scrutinizes whether your degree field directly supports the specific RA duties in the job description. A chemistry or biology degree paired with regulatory coursework strengthens specialty occupation arguments far more than a general science background.
Search LCA filings before applying anywhere
Use Migrate Mate to filter employers by verified DOL LCA filing history in Regulatory Affairs. This surfaces companies that have already demonstrated H-1B sponsorship intent for this job code, cutting your search time significantly.
Target employers with dedicated RA departments
Standalone RA departments at mid-size pharma and Class II medical device companies sponsor more consistently than generalist consulting firms. O*NET classifies Regulatory Affairs Specialists under SOC 13-1041, which you can cross-reference against OFLC disclosure data.
Negotiate LCA filing into your offer timeline
The DOL must certify your LCA before USCIS receives the I-129 petition. Ask your employer to begin the LCA at least three weeks before your intended start date so certification doesn't delay your H-1B effective date.
Document foreign regulatory experience for RFEs
If you've worked with EMA, Health Canada, or TGA submissions, get official employer letters specifying submission types and your exact role. USCIS RFEs on RA petitions frequently challenge whether non-U.S. experience maps to the specialty occupation standard.
Verify your employer's E-Verify enrollment status
H-1B employers must be E-Verify participants to request cap-exempt processing through certain institutions or to rehire H-1B workers portably. Confirm enrollment before your final offer acceptance, not after signing.
H-1B Visa Regulatory Affairs: Frequently Asked Questions
Does a Regulatory Affairs job qualify as an H-1B specialty occupation?
Yes. Regulatory Affairs Specialist roles require theoretical and practical application of life sciences, pharmacy, chemistry, or engineering knowledge at the bachelor's degree level or higher. USCIS has approved H-1B petitions for RA roles across pharma, biotech, and medical device sectors. The employer's job description must specify degree requirements that are directly related to RA duties, not just broadly preferred.
Which industries sponsor H-1B visas most often for Regulatory Affairs professionals?
Pharmaceutical manufacturers, biologics companies, Class II and Class III medical device firms, and CROs file the largest volume of H-1B LCAs for Regulatory Affairs roles. Biotech startups preparing for IND or NDA submissions also sponsor frequently because RA expertise is scarce domestically. You can browse employers with active H-1B filing history for this role category on Migrate Mate.
What happens to my H-1B status if my employer loses an FDA contract or restructures the RA team?
You have a 60-day grace period after involuntary termination to find new H-1B sponsorship, change to another status, or depart the U.S. Under AC21 portability rules, if your I-140 has been approved and your I-485 has been pending for 180 days or more, you can port to a same or similar RA role with a new employer without losing your priority date.
How does the prevailing wage requirement affect H-1B sponsorship for Regulatory Affairs roles?
Your employer must pay at least the DOL prevailing wage for the RA job title, level, and work location. Prevailing wages are set at four wage levels based on experience and complexity. You can look up the applicable wage yourself using the OFLC Wage Search before negotiations. Employers who underpay relative to the certified LCA wage risk DOL audit and back-pay liability.
Can I transfer my H-1B to a new Regulatory Affairs employer mid-sponsorship?
Yes. H-1B portability lets you start working for a new H-1B employer as soon as the new I-129 petition is filed, not after approval. The new role must be in the same or a substantially similar RA occupational classification. Your new employer files a new LCA and I-129; you don't restart the lottery. This makes lateral moves within RA feasible without status gaps.