Regulatory Affairs Lead Jobs in USA with Visa Sponsorship
Regulatory Affairs Lead roles regularly qualify for H-1B visa and O-1 visa sponsorship, as the position meets USCIS specialty occupation standards. Most employers require a bachelor's degree in a life sciences, chemistry, or engineering field, and many sponsor green cards through the EB-2 or EB-3 pathway. 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 2,546+ Regulatory Affairs Lead Jobs
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Get Access To All JobsTips for Finding Regulatory Affairs Lead Jobs
Lead with your regulatory submissions experience
Employers sponsoring Regulatory Affairs Leads want concrete evidence of FDA, EMA, or equivalent agency submissions. Quantify submissions you've led, INDs, NDAs, 510(k)s, so hiring managers can immediately assess your fit and sponsorship value.
Understand your degree's role in the specialty occupation argument
USCIS requires a direct relationship between your degree field and regulatory affairs work. Degrees in pharmacy, biochemistry, biomedical engineering, or chemistry are the strongest fit. Unrelated degrees create risk at the I-129 stage, even with strong experience.
Target employers with an established H-1B filing history
Pharmaceutical companies, medical device manufacturers, and contract research organizations file H-1B visa petitions regularly for this role. Prioritizing employers with a documented sponsorship track record significantly reduces the risk of a first-time denial.
Raise green card sponsorship in second-round interviews
Many employers in regulated industries routinely sponsor Regulatory Affairs Leads for EB-2 or EB-3 green cards after one to two years. Asking about PERM timelines during a second interview is standard practice, not premature, in this field.
Document your role-specific expertise for the RFE scenario
USCIS issues Requests for Evidence for regulatory roles when the job duties seem broad. Keep a file of past regulatory submissions, internal SOPs you've authored, and agency correspondence you've managed, these records are invaluable if your employer needs to respond.
Clarify your authorization status before the offer stage
Disclosing your visa needs early avoids wasted time with employers unwilling to sponsor. Most regulated-industry employers expect sponsorship requests from Regulatory Affairs candidates and factor processing timelines into their hiring plans from the start.
Frequently Asked Questions
Does a Regulatory Affairs Lead role qualify as an H-1B specialty occupation?
Yes, Regulatory Affairs Lead consistently qualifies as a specialty occupation because it requires at minimum a bachelor's degree in a specific technical field, typically pharmacy, chemistry, biomedical engineering, or a related life science. USCIS scrutinizes job descriptions that appear generalist, so the petition should emphasize submission-specific duties and the technical degree requirement rather than broad management responsibilities.
Which employers sponsor H-1B visas for Regulatory Affairs Leads?
Pharmaceutical manufacturers, biologics companies, medical device firms, and contract research organizations are the most active sponsors for this role. Large companies like those in the Fortune 500 pharma sector file regularly, but mid-size device and biotech companies also sponsor frequently given the specialized talent shortage. Browse Migrate Mate to filter for Regulatory Affairs Lead roles at visa-sponsoring employers directly.
Can I qualify for an O-1A visa as a Regulatory Affairs Lead?
It's possible but requires a strong record beyond standard job performance. O-1A requires demonstrated extraordinary ability, peer-reviewed publications on regulatory science, invited presentations at industry conferences, membership on FDA advisory panels, or published guidance contributions would strengthen a petition. A regulatory career that has stayed internal to one company, without external recognition, is unlikely to meet the O-1A bar.
How long does H-1B to green card sponsorship typically take for this role?
For most Regulatory Affairs Leads, the PERM labor certification process takes 12 to 18 months, followed by I-140 approval (6 to 8 months without premium processing). Priority date waiting times then depend heavily on your country of birth. Indian-born applicants face multi-year waits in the EB-2 and EB-3 categories, while applicants born outside India and China often see significantly shorter timelines.
Does my three-year bachelor's degree qualify for H-1B sponsorship in this field?
A three-year bachelor's degree can qualify if USCIS accepts it as equivalent to a U.S. four-year degree, which often requires a credentials evaluation from a recognized assessment organization. For Regulatory Affairs roles, the field of study matters as much as the degree length. A three-year degree in pharmacy or chemistry from an accredited institution generally evaluates favorably; a general science or unrelated degree in any format creates greater petition risk.
What is the prevailing wage requirement for sponsored Regulatory Affairs Lead 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.