OPT Regulatory Affairs Jobs
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.
Find OPT Regulatory Affairs JobsOverview
Showing 5 of 69+ Regulatory Affairs jobs
See all 69+ 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 JobsSchedule:
Monday - Friday (40 hrs/wk)
8:00 AM - 5:00 PM
Department: PharmaDx - 511
Primary Purpose:
The PharmaDx Regulatory Affairs Specialist I supports the development and submission of lab developed tests and companion diagnostics (class III medical devices) to the FDA and other global regulatory bodies for in vitro diagnostic (IVD) approval and/or performance of clinical trials. The PharmaDx Regulatory Affairs Specialist I supports IRB/ethics approval applications, continuing reviews, and decisional support. The Specialist I has knowledge of Design Control and/or PharmaDx’s Product Development Program (PDP) and risk management. The Specialist I serves as regulatory affairs project support on product development teams, assists in supporting the proper implementation of PDP practices by project teams, and reviews PDP documents to ensure their suitability for regulatory filings. The Specialist I is also responsible for supporting preparation of communications to product sponsors and the FDA or other regulatory bodies, as needed. The Specialist I reports to PharmaDx Quality and Regulatory Affairs management.
About ARUP:
ARUP Laboratories is a national clinical and anatomic pathology reference laboratory and an enterprise of the University of Utah and its Department of Pathology. Based in Salt Lake City, Utah.
ARUP proudly hires top talent to create a work environment of diversity, professional growth and continuous development. Our workforce is committed to the important service we provide to over one million patients each month. We always strive for excellence and have a strong desire to have involvement with the advances in medicine and the role laboratory services plays within each patient’s life. We never forget that there is a patient behind every specimen we receive.
We are looking for individuals who want to contribute to ARUP's culture of accountability, integrity, service, and excellence. Consider joining our dynamic team.
Essential Functions
Uses working knowledge of applicable regulations and standards (e.g. ISO, FDA, IVDD/IVDR, CAP/CLIA, GMP, GCP, and other global standards) to contribute to project teams that develop and seek approval for companion diagnostic tests and to support clinical trials.
Supports the regulatory aspects of PharmaDx projects in order to meet requirements, timelines, and deliverables and to maintain compliance with applicable standards, regulations, and policies.
Assists in the preparation of regulatory submission documents for the FDA or other regulatory agencies (e.g., IRB, SRD, IDE, PMA, performance evaluation application, non-US technical dossier).
Works closely with project teams to implement Design Control, risk management, or other applicable principles, and supports associated regulatory submission processes, documents, and submission timelines.
Provides assistance to the project team for implementation of ARUP’s Design Control program as it relates to supporting a responsive and compliant regulatory submission package.
Possesses a working knowledge of Good Documentation Practices and design change control.
Supports authoring and review of PharmaDx policies and procedures to ensure compliance with FDA and other regulatory agencies.
May assist in supporting external audits by sponsors and regulatory authorities.
Supports regulatory-related responses on supplier qualification questionnaires.
Participates in continuous improvement projects.
Supports PharmaDx Quality and Regulatory Affairs management, as needed.
May support onboarding of new team members.
Other duties as assigned.
Physical and Other Requirements:
Stooping: Bending body downward and forward by bending spine at the waist.
Reaching: Extending hand(s) and arm(s) in any direction.
Mobility: The person in this position needs to occasionally move between work sites and inside the office to access file cabinets, office machinery, etc.
Communicate: Frequently and effectively communicate with others.
PPE: Biohazard laboratory environment that requires use of personal protective equipment in accordance with CDC and OSHA regulations and company policies.
ARUP Policies and Procedures: To conduct self in compliance with all ARUP Policies and Procedures.
Sedentary Work: Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects.
Fine Motor Control: Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling.
Experience
Required
Bachelor’s degree in Medical Laboratory Science, Biology, Chemistry or equivalent degree
Two years of experience in pharmaceutical, IVD, or medical device industry working under design control
Preferred
1-2 years of experience in writing regulatory documents
Experience in Good Manufacturing Practice or Good Clinical Practice
Intermediate to advanced experience with Microsoft Word, Excel, and PowerPoint
Demonstrated strong organizational, problem-solving, troubleshooting, and interpersonal skills
One year of experience in regulatory affairs
Education
Required
Bachelor's Degree or better in Biological, Chemical, or Scientific Field or related field
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Schedule:
Monday - Friday (40 hrs/wk)
8:00 AM - 5:00 PM
Department: PharmaDx - 511
Primary Purpose:
The PharmaDx Regulatory Affairs Specialist I supports the development and submission of lab developed tests and companion diagnostics (class III medical devices) to the FDA and other global regulatory bodies for in vitro diagnostic (IVD) approval and/or performance of clinical trials. The PharmaDx Regulatory Affairs Specialist I supports IRB/ethics approval applications, continuing reviews, and decisional support. The Specialist I has knowledge of Design Control and/or PharmaDx’s Product Development Program (PDP) and risk management. The Specialist I serves as regulatory affairs project support on product development teams, assists in supporting the proper implementation of PDP practices by project teams, and reviews PDP documents to ensure their suitability for regulatory filings. The Specialist I is also responsible for supporting preparation of communications to product sponsors and the FDA or other regulatory bodies, as needed. The Specialist I reports to PharmaDx Quality and Regulatory Affairs management.
About ARUP:
ARUP Laboratories is a national clinical and anatomic pathology reference laboratory and an enterprise of the University of Utah and its Department of Pathology. Based in Salt Lake City, Utah.
ARUP proudly hires top talent to create a work environment of diversity, professional growth and continuous development. Our workforce is committed to the important service we provide to over one million patients each month. We always strive for excellence and have a strong desire to have involvement with the advances in medicine and the role laboratory services plays within each patient’s life. We never forget that there is a patient behind every specimen we receive.
We are looking for individuals who want to contribute to ARUP's culture of accountability, integrity, service, and excellence. Consider joining our dynamic team.
Essential Functions
Uses working knowledge of applicable regulations and standards (e.g. ISO, FDA, IVDD/IVDR, CAP/CLIA, GMP, GCP, and other global standards) to contribute to project teams that develop and seek approval for companion diagnostic tests and to support clinical trials.
Supports the regulatory aspects of PharmaDx projects in order to meet requirements, timelines, and deliverables and to maintain compliance with applicable standards, regulations, and policies.
Assists in the preparation of regulatory submission documents for the FDA or other regulatory agencies (e.g., IRB, SRD, IDE, PMA, performance evaluation application, non-US technical dossier).
Works closely with project teams to implement Design Control, risk management, or other applicable principles, and supports associated regulatory submission processes, documents, and submission timelines.
Provides assistance to the project team for implementation of ARUP’s Design Control program as it relates to supporting a responsive and compliant regulatory submission package.
Possesses a working knowledge of Good Documentation Practices and design change control.
Supports authoring and review of PharmaDx policies and procedures to ensure compliance with FDA and other regulatory agencies.
May assist in supporting external audits by sponsors and regulatory authorities.
Supports regulatory-related responses on supplier qualification questionnaires.
Participates in continuous improvement projects.
Supports PharmaDx Quality and Regulatory Affairs management, as needed.
May support onboarding of new team members.
Other duties as assigned.
Physical and Other Requirements:
Stooping: Bending body downward and forward by bending spine at the waist.
Reaching: Extending hand(s) and arm(s) in any direction.
Mobility: The person in this position needs to occasionally move between work sites and inside the office to access file cabinets, office machinery, etc.
Communicate: Frequently and effectively communicate with others.
PPE: Biohazard laboratory environment that requires use of personal protective equipment in accordance with CDC and OSHA regulations and company policies.
ARUP Policies and Procedures: To conduct self in compliance with all ARUP Policies and Procedures.
Sedentary Work: Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects.
Fine Motor Control: Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling.
Experience
Required
Bachelor’s degree in Medical Laboratory Science, Biology, Chemistry or equivalent degree
Two years of experience in pharmaceutical, IVD, or medical device industry working under design control
Preferred
1-2 years of experience in writing regulatory documents
Experience in Good Manufacturing Practice or Good Clinical Practice
Intermediate to advanced experience with Microsoft Word, Excel, and PowerPoint
Demonstrated strong organizational, problem-solving, troubleshooting, and interpersonal skills
One year of experience in regulatory affairs
Education
Required
Bachelor's Degree or better in Biological, Chemical, or Scientific Field or related field
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
See all 69+ OPT Regulatory Affairs Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Regulatory Affairs Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship in Regulatory Affairs
Target regulated industries first
Pharma, biotech, and medical device companies have dedicated regulatory departments and established visa sponsorship pipelines. These employers understand OPT timelines and are far more likely to support H-1B petitions than companies outside regulated industries.
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 OPT: Frequently 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.