Regulatory Affairs Jobs for OPT Students
Regulatory Affairs jobs are a strong fit for OPT students with degrees in pharmacy, biology, chemistry, or engineering. Most roles 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 qualified regulatory professionals.
See All Regulatory Affairs JobsOverview
Showing 5 of 130+ Regulatory Affairs 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 130+ 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 JobsINTRODUCTION
The Regulatory Affairs Associate role is responsible for assisting with preparing and submitting the appropriate documentation for pre-market submissions (i.e. FDA 510(k) submissions, Health Canada Device License Applications). This role also supports post-market regulatory compliance activities.
ROLE AND RESPONSIBILITIES:
- Assisting with responses to deficiency letters and other requests for documentation for submissions.
- Reviews complaints/adverse events for submission of MDRs.
- Review and approve test protocols/reports and other documentation/information for regulatory submissions from various functional areas and check for errors, legibility, and missing information.
- Assist with the development of labeling and ensure compliance with applicable regulations.
- Participate in project development teams and review plans, reports, risk management, risk assessments and design reviews associated with product and process projects.
- Provide regulatory assessments for manufacturing, line extensions, design changes, and validation activities.
- Conduct regulatory review and approval of change orders and related project documentation.
- Implement and maintain unique identifier (UDI) activities for compliance.
- Assists with PFMEA risk assessments.
- Assists in archiving regulatory documentation and maintaining related databases.
- Participate in internal and external audits.
- Assist with other Regulatory projects and activities as required.
BASIC QUALIFICATIONS:
- Minimum of Bachelor's degree (preferably in (i.e. Engineering, Biological Sciences, or other technical field) or equivalent education, training and experience.
- Minimum of one (1) year medical device regulatory and/or quality experience.
- Basic knowledge of FDA 21 CFR Part 820, ISO13485, and 510(k) submission requirements preferred.
- Basic knowledge of Canadian Medical Device Regulations, MDD, MDSAP and ISO standards preferred.
- High degree of initiative, be able to balance a variety of tasks, and with strong organizational abilities.
- Strong commitment to quality, accuracy and detail.
- Excellent oral and written communications skills.
- Excellent interpersonal skills are required, due to the numerous internal customers with varying and unique requirements/priorities. Must understand the nature of the work and the impact it has on the organization.
- Ability to work in a fast paced/entrepreneurial team environment.
- Proficient in computer applications (i.e. Microsoft Office, Word, PowerPoint, Excel, etc.)
INTRODUCTION
The Regulatory Affairs Associate role is responsible for assisting with preparing and submitting the appropriate documentation for pre-market submissions (i.e. FDA 510(k) submissions, Health Canada Device License Applications). This role also supports post-market regulatory compliance activities.
ROLE AND RESPONSIBILITIES:
- Assisting with responses to deficiency letters and other requests for documentation for submissions.
- Reviews complaints/adverse events for submission of MDRs.
- Review and approve test protocols/reports and other documentation/information for regulatory submissions from various functional areas and check for errors, legibility, and missing information.
- Assist with the development of labeling and ensure compliance with applicable regulations.
- Participate in project development teams and review plans, reports, risk management, risk assessments and design reviews associated with product and process projects.
- Provide regulatory assessments for manufacturing, line extensions, design changes, and validation activities.
- Conduct regulatory review and approval of change orders and related project documentation.
- Implement and maintain unique identifier (UDI) activities for compliance.
- Assists with PFMEA risk assessments.
- Assists in archiving regulatory documentation and maintaining related databases.
- Participate in internal and external audits.
- Assist with other Regulatory projects and activities as required.
BASIC QUALIFICATIONS:
- Minimum of Bachelor's degree (preferably in (i.e. Engineering, Biological Sciences, or other technical field) or equivalent education, training and experience.
- Minimum of one (1) year medical device regulatory and/or quality experience.
- Basic knowledge of FDA 21 CFR Part 820, ISO13485, and 510(k) submission requirements preferred.
- Basic knowledge of Canadian Medical Device Regulations, MDD, MDSAP and ISO standards preferred.
- High degree of initiative, be able to balance a variety of tasks, and with strong organizational abilities.
- Strong commitment to quality, accuracy and detail.
- Excellent oral and written communications skills.
- Excellent interpersonal skills are required, due to the numerous internal customers with varying and unique requirements/priorities. Must understand the nature of the work and the impact it has on the organization.
- Ability to work in a fast paced/entrepreneurial team environment.
- Proficient in computer applications (i.e. Microsoft Office, Word, PowerPoint, Excel, etc.)
How to Get Visa Sponsorship in Regulatory Affairs
Confirm your degree qualifies for STEM OPT
Regulatory Affairs roles typically require a STEM-classified degree such as biology, chemistry, pharmaceutical sciences, or biomedical engineering. Confirm your CIP code with your DSO before applying, since STEM OPT extension eligibility determines whether you get 12 or 36 months of work authorization.
Highlight relevant regulatory experience upfront
Employers weigh FDA submission experience, quality systems knowledge, and familiarity with regulations like 21 CFR heavily. Feature these in your resume summary and cover letter so hiring managers immediately understand your technical fit before evaluating your visa status.
Ask about sponsorship during the recruiter screen
Raise your OPT status during the first recruiter call, not after an offer. Ask directly whether the company has sponsored H-1B visas for Regulatory Affairs roles before. This saves time and signals that you're organized and transparent about your work authorization situation.
Pursue RAC or RAC-P certification proactively
The Regulatory Affairs Certification credential signals professional commitment and reduces employer hesitation around sponsorship. OPT students who hold or are actively pursuing RAC certification stand out in competitive candidate pools, especially for entry-level and associate-level regulatory positions.
Track your OPT end date and plan around H-1B timelines
H-1B petitions must be filed by April 1 for an October 1 start date. If your OPT expires before October, your STEM extension and employer's cap-exempt status matter. Map your authorization window before accepting offers to avoid gaps in employment eligibility.
Regulatory Affairs jobs are hiring across the US. Find yours.
Find Regulatory Affairs JobsSee all 130+ 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 JobsFrequently Asked Questions
Can I work in Regulatory Affairs on OPT?
Yes. Regulatory Affairs roles are eligible for OPT as long as the position is directly related to your degree field. Most qualifying degrees, including pharmacy, biology, chemistry, and biomedical engineering, are STEM-classified, which means you may be eligible for the 24-month STEM OPT extension on top of your initial 12-month authorization period.
Do Regulatory Affairs employers commonly sponsor H-1B visas?
Yes, particularly in pharma, biotech, and medical device companies. Regulatory Affairs is a specialized technical function, and employers in these industries have well-established H-1B sponsorship processes. Smaller companies and contract research organizations may sponsor less frequently, so it's worth confirming sponsorship history before investing time in the interview process. Migrate Mate filters job listings by sponsorship willingness to help you find the right fit.
What degrees qualify for STEM OPT extension in Regulatory Affairs?
Degrees in pharmaceutical sciences, biology, chemistry, biochemistry, biomedical engineering, and related STEM fields typically qualify. Your degree's CIP code determines eligibility, not the job title itself. Confirm your CIP code with your Designated School Official before applying for the extension. A qualifying STEM degree gives you up to 36 total months of OPT work authorization, which significantly expands your H-1B sponsorship window.
How should I explain my OPT status to a Regulatory Affairs employer?
Be direct and factual during the recruiter screen. Explain that you're authorized to work on OPT, specify your authorization end date, and note whether you qualify for the STEM extension. Mention that you'll need H-1B sponsorship before OPT expires. Regulatory Affairs employers in pharma and biotech are accustomed to this conversation and generally respond well to candidates who are organized and proactive about it.
What types of Regulatory Affairs roles are most accessible for OPT students?
Entry-level and associate regulatory affairs specialist roles are the most accessible. Positions focused on document management, submissions coordination, regulatory intelligence, and quality system support often welcome candidates with relevant internship experience and STEM degrees. Senior roles typically require several years of direct FDA interaction experience. Browse current Regulatory Affairs openings on Migrate Mate to find roles that specifically welcome OPT candidates.
See which Regulatory Affairs employers are hiring and sponsoring visas right now.
Search Regulatory Affairs Jobs