Regulatory Affairs Associate Jobs in USA with Visa Sponsorship
Regulatory Affairs Associates working in pharmaceuticals, medical devices, and biotech regularly receive H-1B visa and O-1 visa sponsorship. The role qualifies as a specialty occupation requiring a bachelor's degree or higher in a scientific or regulatory field, making employer sponsorship straightforward for qualified candidates. For detailed occupation requirements, see the O*NET profile.
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Get Access To All JobsINTRODUCTION
AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE® probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures.
We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.
Position Summary:
This position will originate appropriate documents to obtain and maintain marketing privileges consistent with applicable government requirements where AtriCure conducts business. This position will also maintain internal documentation of such approvals and handle requests for documentation from our international distributors and customers. This position is responsible for practicing Quality System Manual procedures and complying with its requirements, and carrying out responsibilities as outlined in safety, health and environmental policies.
ESSENTIAL FUNCTIONS OF THE POSITION:
- Support global regulatory pre-market applications for geographies included but not limited to: Taiwan, Singapore, Australia, Brazil, Korea, UAE, EU, UK, U.S, Japan, and Canada. Submission support may include but is not limited to: IDEs, PMA submissions and supplements or 510k for US, EU Technical Documentation, and/or Japan Shonin.
- Support global regulatory post-market activities for the responsible geographies above, such as updating 510(k) letters to file, Technical Files and Design Dossiers on an annual basis, preparing and submitting product renewals, and annual/post-approval reports.
- Support product marketing in additional geographies, as necessary, with international regulatory submissions, product renewals, tender bids, and fulfilling custom requirements.
- Request Certificates to Foreign government and Free Sale Certificates as new products are approved.
- Obtain notarization and legalization of documents as required.
- Maintain, update and track open regulatory requests. Provide periodic status updates on open and closed requests.
- Review of product and manufacturing changes for compliance with applicable regulations (Change Control).
- Work with Regulatory Affairs staff, engineers and technical experts to resolve potential regulatory issues, deficiencies and questions from regulatory agencies.
- Maintain submission correspondence files and other regulatory files in a complete manner.
- Maintain regulatory files for product compliance.
- Perform other related duties as assigned in support of regulatory activities.
- Assist in interacting with reviewers from regulatory agencies on specific projects.
- Provide support during internal and external audits.
- Maintain current knowledge of worldwide regulatory requirements.
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
- Regular and predictable work performance.
- Ability to work under fast-paced conditions.
- Ability to make decisions and use good judgement.
- Ability to prioritize various duties and multitask as required.
- Ability to successfully work with others.
- Additional duties as assigned.
- Hybrid environment (with remote possibilities).
- Travel responsibilities to AtriCure facilities for team functions and activities when needed.
BASIC QUALIFICATIONS:
- Bachelor's degree in a technical/scientific/life science discipline required or 3+ years of Regulatory experience in the medical device industry.
- Proficient on programs within Microsoft Office.
- Written and verbal communication skills.
- Problem solving and/or troubleshooting experience.
PREFERRED QUALIFICATIONS:
- Minimum of 2 years of experience in the medical device industry.
- Basic knowledge of U.S. and/or European/International regulations and standards.
- Strong understanding of documentation within a quality management system.
- Team oriented and able to effectively manage and prioritize multiple projects.
- General knowledge of medical terminology.
OTHER REQUIREMENTS:
- Ability to regularly walk, sit, or stand as needed.
- Ability to occasionally bend and push/pull as needed.
- Ability to pass pre-employment drug screen and background check.
- Occasional travel may be required.
MN Hiring Range:
$85,000-104,000
AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 30 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria.
AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).
INTRODUCTION
AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE® probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures.
We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.
Position Summary:
This position will originate appropriate documents to obtain and maintain marketing privileges consistent with applicable government requirements where AtriCure conducts business. This position will also maintain internal documentation of such approvals and handle requests for documentation from our international distributors and customers. This position is responsible for practicing Quality System Manual procedures and complying with its requirements, and carrying out responsibilities as outlined in safety, health and environmental policies.
ESSENTIAL FUNCTIONS OF THE POSITION:
- Support global regulatory pre-market applications for geographies included but not limited to: Taiwan, Singapore, Australia, Brazil, Korea, UAE, EU, UK, U.S, Japan, and Canada. Submission support may include but is not limited to: IDEs, PMA submissions and supplements or 510k for US, EU Technical Documentation, and/or Japan Shonin.
- Support global regulatory post-market activities for the responsible geographies above, such as updating 510(k) letters to file, Technical Files and Design Dossiers on an annual basis, preparing and submitting product renewals, and annual/post-approval reports.
- Support product marketing in additional geographies, as necessary, with international regulatory submissions, product renewals, tender bids, and fulfilling custom requirements.
- Request Certificates to Foreign government and Free Sale Certificates as new products are approved.
- Obtain notarization and legalization of documents as required.
- Maintain, update and track open regulatory requests. Provide periodic status updates on open and closed requests.
- Review of product and manufacturing changes for compliance with applicable regulations (Change Control).
- Work with Regulatory Affairs staff, engineers and technical experts to resolve potential regulatory issues, deficiencies and questions from regulatory agencies.
- Maintain submission correspondence files and other regulatory files in a complete manner.
- Maintain regulatory files for product compliance.
- Perform other related duties as assigned in support of regulatory activities.
- Assist in interacting with reviewers from regulatory agencies on specific projects.
- Provide support during internal and external audits.
- Maintain current knowledge of worldwide regulatory requirements.
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
- Regular and predictable work performance.
- Ability to work under fast-paced conditions.
- Ability to make decisions and use good judgement.
- Ability to prioritize various duties and multitask as required.
- Ability to successfully work with others.
- Additional duties as assigned.
- Hybrid environment (with remote possibilities).
- Travel responsibilities to AtriCure facilities for team functions and activities when needed.
BASIC QUALIFICATIONS:
- Bachelor's degree in a technical/scientific/life science discipline required or 3+ years of Regulatory experience in the medical device industry.
- Proficient on programs within Microsoft Office.
- Written and verbal communication skills.
- Problem solving and/or troubleshooting experience.
PREFERRED QUALIFICATIONS:
- Minimum of 2 years of experience in the medical device industry.
- Basic knowledge of U.S. and/or European/International regulations and standards.
- Strong understanding of documentation within a quality management system.
- Team oriented and able to effectively manage and prioritize multiple projects.
- General knowledge of medical terminology.
OTHER REQUIREMENTS:
- Ability to regularly walk, sit, or stand as needed.
- Ability to occasionally bend and push/pull as needed.
- Ability to pass pre-employment drug screen and background check.
- Occasional travel may be required.
MN Hiring Range:
$85,000-104,000
AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 30 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria.
AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).
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Get Access To All JobsTips for Finding Visa Sponsorship as a Regulatory Affairs Associate
Target FDA-regulated industries first
Pharmaceutical, biotech, and medical device companies have established immigration programs and sponsor Regulatory Affairs Associates at higher rates than other sectors. These employers file LCAs and H-1B petitions routinely, which means faster internal approval processes for sponsorship requests.
Document your degree's relevance to the role
USCIS requires a direct relationship between your degree field and the job duties. Degrees in life sciences, chemistry, pharmacology, or biomedical engineering map cleanly. If your degree is adjacent, gather course transcripts that demonstrate regulatory, scientific, or compliance coursework.
Highlight submission experience in your resume
Employers sponsoring H-1B petitions need to prove the role requires specialized knowledge. Listing specific submissions, such as 510(k)s, INDs, or CTAs, strengthens both your candidacy and the specialty occupation argument USCIS evaluates during petition review.
Apply to companies with existing RAA headcount
Companies that already employ Regulatory Affairs Associates on H-1B status have proven their HR and legal teams can handle the process. Joining an established regulatory department significantly reduces friction compared to being the first sponsored employee in that function.
Understand the H-1B lottery timing before accepting offers
If you need cap-subject H-1B sponsorship, registration opens in March for an October 1 start. Clarify your current status and timeline with each employer early in interviews so both parties understand what bridging arrangements, such as OPT extension, may be needed.
Consider contract and CRO roles as entry points
Contract Research Organizations and staffing agencies that place regulatory professionals often sponsor visas and can be faster to move than large pharma legal teams. A contract role with sponsorship builds U.S. regulatory experience that strengthens future full-time petitions.
Frequently Asked Questions
Does a Regulatory Affairs Associate role qualify as an H-1B specialty occupation?
Yes. Regulatory Affairs Associate positions consistently qualify as H-1B visa specialty occupations because they require at least a bachelor's degree in a specific scientific or regulatory field, life sciences, chemistry, biomedical engineering, or pharmacy are the most common. USCIS has approved thousands of H-1B petitions for this job title across pharmaceutical and medical device companies. The role's technical complexity and degree requirement make denial on specialty occupation grounds uncommon when the petition is properly documented.
Which visa types do Regulatory Affairs Associates most commonly receive sponsorship for?
H-1B is the most common visa for Regulatory Affairs Associates. Candidates with extraordinary achievement in regulatory science, such as published research or leadership on major submissions, sometimes qualify for O-1A. Australians with the right credentials should explore the E-3 visa, which skips the H-1B lottery entirely and is easier for employers to process. Use Migrate Mate to filter job listings by visa type and identify which sponsoring employers are actively hiring.
Do employers in pharma and biotech routinely sponsor Regulatory Affairs Associates?
Yes, sponsorship rates are high in this field. Large pharmaceutical companies, mid-size biotechs, and medical device manufacturers all hire internationally and have immigration counsel on retainer. DOL LCA disclosure data consistently shows companies like Johnson & Johnson, Pfizer, and Abbott filing for Regulatory Affairs roles. Smaller companies and startups sponsor less predictably, so it is worth confirming sponsorship willingness early in the interview process.
Can I qualify for Regulatory Affairs Associate sponsorship with a non-science degree?
It depends on the specific degree and how closely it relates to the regulatory function. A degree in public health, law, or even engineering can support a petition if your coursework or professional experience maps to regulatory compliance. USCIS evaluates whether the degree is in a directly related field. A credential evaluation and a strong job description tying your background to regulatory requirements will be necessary. An immigration attorney can assess your specific profile before you apply.
What documents does my employer need to sponsor my H-1B as a Regulatory Affairs Associate?
Your employer needs to file a Labor Condition Application with the Department of Labor, then submit Form I-129 to USCIS with supporting documentation. That includes a detailed job description outlining the regulatory duties and degree requirements, proof of your qualifications, and evidence the employer can pay the prevailing wage. For Regulatory Affairs roles, employers often include examples of the regulatory submissions the position manages to strengthen the specialty occupation argument.
What is the prevailing wage requirement for sponsored Regulatory Affairs Associate jobs?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.