Regulatory Affairs Associate Jobs for OPT Students
Regulatory Affairs Associate jobs are a strong fit for F-1 OPT students with backgrounds in life sciences, 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 visas for this function.
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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 as a Regulatory Affairs Associate
Target STEM-designated programs
Regulatory Affairs Associate roles typically fall under STEM OPT CIP codes in life sciences or engineering. Confirm your degree qualifies before applying so you can accurately represent your 36-month authorization window to employers.
Focus on regulated industries
Pharma, biotech, and medical device companies file for H-1B sponsorship at far higher rates than other sectors. Prioritize employers who already have regulatory teams, since those departments understand visa timelines and specialty occupation requirements for this role.
Highlight your degree field alignment
H-1B approval for regulatory roles depends on showing your degree directly relates to the job. Emphasize coursework in pharmacology, chemistry, toxicology, or biomedical engineering in your resume to establish that connection clearly.
Disclose your OPT timeline early
Regulatory hiring cycles can run three to six months. Mention your OPT end date in your first conversation so employers can plan whether sponsorship timing is feasible before investing in a lengthy interview process.
Get your EAD card details ready
Employers need your EAD card number, start date, and expiration date for onboarding and I-9 verification. Having a clean copy of your card and your SEVIS record accessible avoids delays once an offer is extended.
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Get Access To All JobsFrequently Asked Questions
Does a Regulatory Affairs Associate role qualify for STEM OPT extension?
It depends on your degree, not the job title. If your degree falls under an approved STEM CIP code, such as biology, chemistry, or biomedical engineering, and your employer is E-Verify enrolled, you can apply for the 24-month STEM extension. Most regulatory roles at life sciences companies meet both conditions, but confirm your specific CIP code with your DSO before applying.
How do I find Regulatory Affairs Associate jobs that sponsor OPT?
Migrate Mate is built specifically for F-1 OPT and visa-sponsored job searches. Browsing Migrate Mate lets you filter for employers who have demonstrated sponsorship histories, so you're not wasting applications on companies that have never filed for a work visa. Regulatory roles in pharma and medical devices appear regularly on the platform.
Is Regulatory Affairs Associate considered a specialty occupation for H-1B purposes?
Yes, in most cases. USCIS has consistently approved H-1B petitions for regulatory affairs roles when the petition establishes that the position requires at minimum a bachelor's degree in a specific scientific field. The key is that your employer's job description must specify a degree requirement tied to a particular discipline, not just any bachelor's degree.
Can I start a Regulatory Affairs Associate job before my OPT EAD card arrives?
No. You cannot begin working until you have your physical EAD card in hand and the start date printed on it has passed. USCIS processing currently takes two to three months, so apply for OPT at least 90 days before your intended start date. Your DSO can provide a timeline specific to your program end date.
What happens to my OPT if I'm laid off from a Regulatory Affairs Associate position?
F-1 OPT allows up to 90 days of unemployment in total, or 150 days on an approved STEM extension. If you're laid off, that unemployment clock starts immediately. Notify your DSO right away and begin your job search. Regulatory affairs roles have consistent demand in pharma and device companies, so targeted outreach to those sectors typically yields results within the unemployment window.
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