Regulatory Affairs Specialist Jobs for OPT Students
Regulatory Affairs Specialist roles are a strong fit for F-1 OPT students with degrees in life sciences, pharmacy, chemistry, or engineering. Most positions qualify as STEM OPT extensions, giving you up to 36 months of work authorization. Employers in pharma, biotech, and medical devices regularly sponsor H-1B visas for this role.
See All Regulatory Affairs Specialist JobsOverview
Showing 5 of 58+ Regulatory Affairs Specialist jobs
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
See all 58+ Regulatory Affairs Specialist jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Regulatory Affairs Specialist roles.
Get Access To All JobsJob Description: Regulatory Affairs Specialist – Medical Devices
Location: Minnesota, United States
Job Summary
The Regulatory Affairs Specialist will be responsible for supporting regulatory submissions, ensuring compliance with global medical device regulations, and facilitating timely market access. The role involves close collaboration with cross-functional teams to maintain regulatory compliance throughout the product lifecycle.
Roles & Responsibilities
- Prepare and submit regulatory applications (e.g., 510(k), PMA, CE Marking)
- Compile and maintain Technical Documentation and Design Dossiers
- Ensure compliance with FDA (21 CFR), EU MDR (2017/745), and ISO 13485
- Review labeling, Instructions for Use (IFU), and promotional materials
- Coordinate with regulatory authorities and notified bodies
- Support change control, post-market surveillance, and vigilance reporting
- Maintain regulatory records and documentation systems
- Track regulatory changes and assess business impact
- Collaborate with R&D, Quality Assurance, Clinical, and Manufacturing teams
Educational Qualification
Bachelor’s degree in Life Sciences / Biomedical Engineering / Pharmacy or related field
Required Skills
- Knowledge of US FDA regulations and EU MDR
- Familiarity with ISO 13485 and regulatory frameworks
- Strong documentation and organizational skills
- Good communication and coordination abilities
- Experience with global submissions (Canada, Australia, etc.)
- Knowledge of ISO 14971 (Risk Management)
- RAC certification is an advantage
Experience Required
2–6 years of experience in regulatory affairs (medical devices)
Hands-on experience in regulatory submissions and documentation
Job Description: Regulatory Affairs Specialist – Medical Devices
Location: Minnesota, United States
Job Summary
The Regulatory Affairs Specialist will be responsible for supporting regulatory submissions, ensuring compliance with global medical device regulations, and facilitating timely market access. The role involves close collaboration with cross-functional teams to maintain regulatory compliance throughout the product lifecycle.
Roles & Responsibilities
- Prepare and submit regulatory applications (e.g., 510(k), PMA, CE Marking)
- Compile and maintain Technical Documentation and Design Dossiers
- Ensure compliance with FDA (21 CFR), EU MDR (2017/745), and ISO 13485
- Review labeling, Instructions for Use (IFU), and promotional materials
- Coordinate with regulatory authorities and notified bodies
- Support change control, post-market surveillance, and vigilance reporting
- Maintain regulatory records and documentation systems
- Track regulatory changes and assess business impact
- Collaborate with R&D, Quality Assurance, Clinical, and Manufacturing teams
Educational Qualification
Bachelor’s degree in Life Sciences / Biomedical Engineering / Pharmacy or related field
Required Skills
- Knowledge of US FDA regulations and EU MDR
- Familiarity with ISO 13485 and regulatory frameworks
- Strong documentation and organizational skills
- Good communication and coordination abilities
- Experience with global submissions (Canada, Australia, etc.)
- Knowledge of ISO 14971 (Risk Management)
- RAC certification is an advantage
Experience Required
2–6 years of experience in regulatory affairs (medical devices)
Hands-on experience in regulatory submissions and documentation
How to Get Visa Sponsorship as a Regulatory Affairs Specialist
Confirm your degree qualifies for STEM OPT
Regulatory Affairs roles typically qualify for the 24-month STEM OPT extension if your degree is in biology, chemistry, pharmacy, or a related field. Verify your CIP code with your DSO before applying so you know your full authorization window upfront.
Highlight regulatory database experience on your resume
Familiarity with FDA submission systems, eCTD formatting, or ICH guidelines signals job-readiness to hiring managers. Specific technical knowledge reduces employer hesitation about the time investment required to train an OPT hire before sponsorship becomes relevant.
Ask about H-1B sponsorship before accepting an offer
Regulatory Affairs positions are specialty occupations that meet H-1B criteria, but not every employer actively sponsors. Confirm willingness to sponsor during the offer stage, not after you've started, so you can plan your immigration timeline without surprises.
Pursue RAC or RAPS certification if you're early career
The Regulatory Affairs Certification from RAPS signals credibility in a field where credentials matter. Even pursuing coursework demonstrates commitment to the profession, which can reassure employers considering the additional overhead of sponsoring a work visa.
Regulatory Affairs Specialist jobs are hiring across the US. Find yours.
Find Regulatory Affairs Specialist JobsSee all 58+ Regulatory Affairs Specialist jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Regulatory Affairs Specialist roles.
Get Access To All JobsFrequently Asked Questions
Does a Regulatory Affairs Specialist role qualify for the STEM OPT extension?
Yes, in most cases. If your undergraduate or graduate degree is in a STEM field such as biology, chemistry, pharmaceutical sciences, or biomedical engineering, your role will typically qualify for the 24-month STEM OPT extension. Confirm your degree's CIP code with your DSO, since the extension is tied to your degree classification, not the job title itself.
Is Regulatory Affairs Specialist considered a specialty occupation for H-1B purposes?
Yes. Regulatory Affairs Specialist positions generally qualify as specialty occupations under H-1B rules because they require at minimum a bachelor's degree in a specific field such as life sciences, chemistry, or pharmacy. USCIS has consistently approved H-1B petitions for this role when the degree requirement is clearly documented in the job description and employer attestation.
Which types of employers are most likely to sponsor OPT students in regulatory affairs?
Pharmaceutical companies, biotechnology firms, medical device manufacturers, and contract research organizations are the most active sponsors for this role. These companies operate under FDA oversight and maintain in-house regulatory teams that file H-1B petitions routinely. You can browse OPT-friendly regulatory affairs openings directly on Migrate Mate, which filters for employers open to sponsorship.
What happens if my OPT expires before the H-1B October 1 start date?
If your employer files an H-1B petition on your behalf before your OPT expires, you're covered by cap-gap protection, which automatically extends your work authorization through September 30. Your employer must file before your OPT end date for cap-gap to apply. Work with your DSO and employer's immigration counsel to confirm the filing timeline well in advance.
Do I need to disclose my OPT status when applying for Regulatory Affairs roles?
You don't have to disclose it upfront in your application, but employers will ask about work authorization status before extending an offer. Being prepared to explain your OPT timeline, STEM extension eligibility, and H-1B sponsorship needs clearly and confidently tends to reduce employer hesitation. Framing your remaining authorization window accurately helps employers assess whether the timeline works for their hiring plans.
See which Regulatory Affairs Specialist employers are hiring and sponsoring visas right now.
Search Regulatory Affairs Specialist Jobs