Regulatory Affairs Director Jobs in USA with Visa Sponsorship
Regulatory Affairs Directors are strong H-1B visa sponsorship candidates. The role qualifies as a specialty occupation requiring advanced scientific or regulatory knowledge, and employers routinely sponsor because qualified candidates with FDA, EMA, or ICH experience are difficult to source domestically. 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).
See all 1,343+ Regulatory Affairs Director Jobs
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Get Access To All JobsTips for Finding Regulatory Affairs Director Jobs
Lead with your regulatory framework expertise
Employers sponsor when they can't find local talent. Emphasize specific frameworks you've worked within, such as FDA 21 CFR, ICH Q10, or EMA guidelines. Concrete regulatory experience signals you fill a genuine skills gap.
Target companies with active IND or BLA pipelines
Biotech and pharmaceutical companies with live investigational drug or biologics applications have urgent regulatory timelines. They're far more likely to sponsor quickly because regulatory delays cost millions and headcount gaps directly threaten approval schedules.
Highlight cross-border submission experience
Directors who've managed submissions across multiple jurisdictions simultaneously, such as FDA and Health Canada or EMA in parallel, are genuinely rare. This global dossier experience is a concrete reason employers initiate H-1B sponsorship for the right candidate.
Confirm your degree field aligns with the specialty occupation standard
USCIS requires your bachelor's degree or higher to be in a directly related field. Degrees in pharmacy, chemistry, biology, or regulatory science are strong. A business degree alone, without advanced scientific coursework, can complicate the petition.
Engage employers before H-1B lottery season closes
H-1B registrations open in March for an October start date. If you're targeting cap-subject employers, start conversations no later than January so the employer has time to engage immigration counsel and prepare your registration before the window closes.
Ask specifically about cap-exempt employer options
Hospitals, nonprofit research institutions, and universities are cap-exempt, meaning they can file H-1B petitions year-round without lottery risk. Regulatory roles exist in academic medical centers and research hospitals, and these employers often sponsor outside the annual cap.
Frequently Asked Questions
Does a Regulatory Affairs Director role qualify as an H-1B specialty occupation?
Yes, in most cases. USCIS evaluates whether the position normally requires a bachelor's degree or higher in a specific field. Regulatory Affairs Director roles typically require degrees in pharmacy, life sciences, chemistry, or a related discipline, and the complexity of FDA or EMA regulatory strategy satisfies the specialty occupation standard. Petition strength depends on how the employer's job description is written, so vague requirements can create problems.
How common is H-1B sponsorship for Regulatory Affairs Directors?
Sponsorship is relatively common in pharmaceutical, biotech, and medical device companies because qualified candidates with specific regulatory expertise, particularly in FDA submissions or international dossier management, are difficult to source locally. Mid-size and large companies with established legal infrastructure are the most reliable sponsors. You can browse current openings from sponsoring employers directly on Migrate Mate, which filters specifically for visa-sponsoring companies.
What degree does USCIS expect for a Regulatory Affairs Director H-1B petition?
USCIS looks for a degree in a field directly related to the job duties. Pharmacy, biochemistry, chemistry, biology, regulatory affairs, or a related life science field are strong matches. An MBA or general business degree alone is unlikely to support the petition unless paired with significant graduate-level scientific coursework. Some employers supplement a borderline degree with expert opinion letters from academic professionals attesting to field equivalency.
Can a Regulatory Affairs Director petition qualify for O-1A visa sponsorship instead?
Possibly, for senior directors with a documented record of distinction. The O-1A requires evidence of extraordinary ability, such as peer-reviewed publications, judging industry submissions, authoring regulatory guidance that was adopted, or speaking at major conferences. Directors at the VP level or above who've led landmark drug approvals may have a credible O-1A case. It's worth discussing with an immigration attorney if your H-1B lottery odds are a concern.
Does regulatory affairs experience outside the U.S. count toward H-1B eligibility?
Yes. Foreign regulatory experience, such as managing EMA, TGA, or Health Canada submissions, is directly relevant and strengthens an H-1B petition. USCIS evaluates credentials and experience in the context of the offered position, not where that experience was gained. Foreign degrees may require a credential evaluation by a NACES-member organization to confirm U.S. equivalency, which your employer's immigration attorney will typically arrange as part of the petition process.
What is the prevailing wage requirement for sponsored Regulatory Affairs Director 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.