OPT Regulatory Affairs Manager Jobs
Regulatory Affairs Manager jobs on OPT require employers to sponsor work authorization before your OPT period ends. Most roles sit inside pharma, biotech, or medical device companies and expect a degree in life sciences, chemistry, or a related field. STEM OPT extension eligibility is common for this role.
Find OPT Regulatory Affairs Manager JobsOverview
Showing 5 of 77+ Regulatory Affairs Manager jobs
See all 77+ Regulatory Affairs Manager Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Regulatory Affairs Manager 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 Manager Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Regulatory Affairs Manager Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship as a Regulatory Affairs Manager
Target STEM-designated programs first
Regulatory Affairs Manager roles frequently fall under STEM OPT extension eligibility. Confirm your degree program's CIP code qualifies before applying, as this gives you up to 24 additional months of work authorization to secure H-1B visa sponsorship.
Focus on regulated industries with established immigration programs
Pharma, biotech, and medical device companies sponsor OPT workers far more consistently than other sectors. These industries have compliance-driven hiring structures and legal teams already familiar with work authorization timelines, making sponsorship conversations less friction-heavy.
Lead with your regulatory credentials in applications
RAC certification, FDA submission experience, or hands-on work with 510(k) or IND filings signals specialized expertise. Employers weigh sponsorship costs against candidate value, so concrete credentials make the business case for sponsoring your visa status stronger.
Time your applications around your OPT expiration window
Apply at least six months before OPT expires so employers have runway to file an H-1B petition or explore cap-exempt options. Hiring managers need time for internal approvals, and compressing that timeline often kills otherwise viable sponsorship conversations.
Understand the specialty occupation argument for your role
Regulatory Affairs Manager qualifies as a specialty occupation because it requires a specific life sciences or engineering degree. Being able to articulate that clearly to a hiring manager removes a common objection and shows you understand the visa process.
Ask about sponsorship policy during the first interview
Raise work authorization early rather than after an offer. Ask specifically whether the company has sponsored H-1B petitions for this role before. A prior sponsorship history in regulatory affairs is the strongest signal that sponsorship is genuinely available.
Regulatory Affairs Manager OPT: Frequently Asked Questions
Does a Regulatory Affairs Manager role qualify for the STEM OPT extension?
It depends on your underlying degree. If your degree is in a STEM-designated field such as biochemistry, biomedical engineering, chemistry, or pharmaceutical sciences, you likely qualify for the 24-month STEM OPT extension. The extension is tied to your degree's CIP code, not your job title. Confirm your program qualifies through your DSO before accepting an offer that depends on the extended timeline.
What types of employers hire Regulatory Affairs Managers on OPT?
Pharmaceutical companies, biotechs, medical device manufacturers, and contract research organizations are the most active sponsors for this role. These employers operate in heavily regulated environments where regulatory affairs expertise is a core business function, not a peripheral one, making them more willing to invest in sponsorship. Browse Migrate Mate to filter specifically for employers that have sponsored OPT workers in this field.
Can I work as a Regulatory Affairs Manager on standard 12-month OPT without a STEM extension?
Yes. Standard OPT authorizes full-time employment in a role related to your degree field, and Regulatory Affairs Manager qualifies if your degree is in life sciences, chemistry, engineering, or a closely related discipline. The practical challenge is that 12 months is a short window for an employer to initiate H-1B sponsorship, so companies with experience sponsoring OPT workers are a better fit than those new to the process.
Does the Regulatory Affairs Manager role qualify as a specialty occupation for H-1B purposes?
Generally yes. The role requires specialized knowledge of regulatory frameworks such as FDA regulations, EU MDR, or ICH guidelines, and a specific bachelor's degree or higher in a related field is the standard entry requirement. USCIS has approved H-1B petitions for regulatory affairs roles consistently, though individual petition outcomes depend on how the employer defines the position in the Labor Condition Application.
What should I do if an employer says they don't sponsor visas for this role?
First, clarify whether they mean H-1B specifically or all work authorization. Some employers are unfamiliar with OPT, which doesn't require them to file a petition and has minimal administrative burden. If they still decline, prioritize employers with a documented sponsorship history. Focusing your search on verified sponsoring employers from the start saves significant time.