OPT Regulatory Affairs Specialist Jobs
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.
Find OPT Regulatory Affairs Specialist JobsOverview
Showing 5 of 77+ Regulatory Affairs Specialist jobs
See all 77+ 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 JobsRole Summary:
Responsible for global coordination and preparation of regulatory submission documents/packages for Baxter medical devices. The role involves reviewing technical/scientific data, supporting regulatory strategies, preparing responses to regulatory authorities, and ensuring regulatory documentation meets applicable requirements across the U.S. and international markets, especially EU regulations.
Key Responsibilities:
- Support execution of regulatory project plans.
- Compile and prepare global regulatory submissions.
- Review technical and scientific data supporting submissions.
- Prepare responses to questions from regulatory authorities.
- Maintain regulatory files and documentation.
- Assist with labeling, SOPs, and departmental documents.
- Track regulatory submission/documentation status.
- Edit and proofread regulatory documents.
- Participate in cross-functional project teams.
- Manage multiple regulatory projects and priorities.
Must-Haves:
- Experience with medical devices / healthcare regulatory affairs.
- Knowledge of U.S. and OUS device regulations, especially EU regulations.
- Experience developing or supporting Regulatory Affairs strategies.
- Experience working with cross-functional teams.
- Experience interacting with external regulatory authorities, such as FDA and TU V.
- Bachelor's degree in a relevant scientific discipline or equivalent experience.
Role Summary:
Responsible for global coordination and preparation of regulatory submission documents/packages for Baxter medical devices. The role involves reviewing technical/scientific data, supporting regulatory strategies, preparing responses to regulatory authorities, and ensuring regulatory documentation meets applicable requirements across the U.S. and international markets, especially EU regulations.
Key Responsibilities:
- Support execution of regulatory project plans.
- Compile and prepare global regulatory submissions.
- Review technical and scientific data supporting submissions.
- Prepare responses to questions from regulatory authorities.
- Maintain regulatory files and documentation.
- Assist with labeling, SOPs, and departmental documents.
- Track regulatory submission/documentation status.
- Edit and proofread regulatory documents.
- Participate in cross-functional project teams.
- Manage multiple regulatory projects and priorities.
Must-Haves:
- Experience with medical devices / healthcare regulatory affairs.
- Knowledge of U.S. and OUS device regulations, especially EU regulations.
- Experience developing or supporting Regulatory Affairs strategies.
- Experience working with cross-functional teams.
- Experience interacting with external regulatory authorities, such as FDA and TU V.
- Bachelor's degree in a relevant scientific discipline or equivalent experience.
See all 77+ OPT Regulatory Affairs Specialist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Regulatory Affairs Specialist Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship as a Regulatory Affairs Specialist
Target regulated industries first
Pharma, biotech, and medical device companies have dedicated regulatory departments and are accustomed to visa sponsorship. These employers file H-1B petitions regularly, making them far more likely to extend your OPT into full sponsorship than general employers.
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.
Apply early relative to your OPT end date
H-1B cap-subject petitions must be filed in April for an October 1 start. If your OPT expires before October, your employer may need to request a cap-gap extension. Start your job search at least six months before your OPT authorization ends.
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 OPT: Frequently 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.