OPT Regulatory Affairs Lead Jobs
Regulatory Affairs Lead roles are a strong fit for F-1 OPT students with backgrounds in life sciences, 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 this role.
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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 Lead Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Regulatory Affairs Lead Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship in Regulatory Affairs Lead
Target STEM-designated programs
Regulatory Affairs Lead roles typically qualify for the 24-month STEM OPT extension when your degree is in life sciences, chemistry, or engineering. Confirm your degree's CIP code with your DSO before applying to maximize your authorized work period.
Focus on regulated industries
Pharma, biotech, medical device, and food safety companies hire Regulatory Affairs Leads regularly and have established immigration infrastructure. These employers are far more familiar with OPT work authorization than companies in unregulated sectors, reducing friction during hiring.
Highlight submission experience precisely
List specific regulatory submissions you've contributed to, such as 510(k), NDA, BLA, or PMA filings. Employers hiring for a lead role need evidence you can own a submission independently, not just support one.
Address OPT timing proactively
Bring up your OPT end date and STEM extension eligibility early in the process. Regulatory Affairs hiring cycles can run three to six months, and employers need to plan H-1B visa sponsorship timelines around your current authorization window.
Demonstrate knowledge of multiple regulatory bodies
Familiarity with FDA, EMA, Health Canada, or TGA frameworks signals you can support international submissions. Cross-border regulatory experience is increasingly valued and can differentiate your application from candidates with single-agency backgrounds.
Pursue relevant professional credentials
The RAC credential from RAPS is widely recognized and signals regulatory competency to hiring managers. Obtaining or actively pursuing it during OPT strengthens your candidacy and demonstrates commitment to the field beyond your academic background.
Regulatory Affairs Lead OPT: Frequently Asked Questions
Do Regulatory Affairs Lead jobs qualify for the STEM OPT extension?
Most do, but it depends on your underlying degree rather than the job title itself. If your degree carries a STEM-designated CIP code in fields like chemistry, biology, or engineering, and the employer meets the E-Verify requirement, you can apply for the 24-month STEM OPT extension, giving you up to 36 months total. Confirm eligibility with your DSO before accepting an offer.
How do I find Regulatory Affairs Lead roles that are open to OPT students?
Migrate Mate filters job listings specifically for visa-friendly employers, so you can browse Regulatory Affairs Lead openings without wading through postings that exclude work authorization holders. Pharma, biotech, and medical device companies are the most active hirers for this role and are generally experienced with OPT documentation requirements.
Will employers sponsor an H-1B after my OPT ends for this role?
Regulatory Affairs Lead is classified as a specialty occupation under USCIS guidelines because it requires a specific scientific or technical degree, which makes H-1B sponsorship a realistic path. Large pharma and medical device companies sponsor this role regularly. Smaller companies may be willing but less experienced with the process, so it's worth asking directly during interviews.
What should I know about the 60-day grace period if a Regulatory Affairs Lead job falls through?
If your employment ends before your OPT period expires, you have a 60-day grace period to find new employment, transfer to a new visa status, or depart the United States. You cannot work during this window. Given that Regulatory Affairs hiring cycles can take several months, notify your DSO immediately so you can plan your next steps before the clock runs out.
Is a Regulatory Affairs Lead role considered a specialty occupation for OPT purposes?
OPT itself doesn't use the specialty occupation standard, but the role must be directly related to your field of study to qualify as authorized OPT employment. A Regulatory Affairs Lead position drawing on your chemistry, pharmacy, or biomedical engineering degree clearly satisfies this. Your DSO can confirm the match between your CIP code and the role's requirements if you need documentation.