Senior Regulatory Affairs Specialist Jobs in USA with Visa Sponsorship
Senior Regulatory Affairs Specialists are strong candidates for H-1B and O-1 visa sponsorship. The role qualifies as a specialty occupation, requiring a bachelor's degree or higher in regulatory science, chemistry, biology, or a related 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
Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product—an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis—provides a color-coded, 3D model of a patient’s coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMap™Analysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare. Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 500,000 patients worldwide.
ROLE AND RESPONSIBILITIES
The Senior Regulatory Affairs Specialist is responsible for coordinating and supporting regulatory activities pertaining to successful pre-market development, continued new market entry, and post-market activities for Heartflow products. This individual contributor role provides world-class regulatory support for Heartflow products, ensuring compliance with applicable global requirements while proactively navigating evolving regulatory landscapes. This position is responsible for activities related to regulatory approval to market Heartflow products from development to post-market surveillance. He/she will be responsible for the assessment of device changes for regulatory impact and develop strategies for submissions and maintenance of documentation within the shifting framework of regulatory requirements worldwide in an efficient manner.
Job Responsibilities:
- Regulatory Project Management
- Represent Regulatory Affairs on cross-functional teams (as necessary) to ensure regulatory alignment with business objectives and timely submissions.
- Facilitate development of global regulatory strategies for Heartflow products through interfacing with internal (product teams) and external partners (distributors, authorized representatives, international regulatory team).
- Review regulatory strategies with the RA management team to gain alignment on priorities and understanding of risks.
- Establish and maintain collaborative relationships and open communication channels with regulatory authorities and ensure all reporting requirements to external regulatory authorities are completed accurately and on time.
- Regulatory Operations and Compliance
- Maintain regulatory pre-market and post-market commitments and compliance (establishment registrations, certifications, reporting, special controls, etc) and related activities.
- Support development of SOPs and internal guidance.
- Ensure applicable regulatory requirements are considered and appropriately incorporated into projects to ensure compliance.
- Manage worldwide submissions for new products and product changes as required to ensure timely approval for clinical studies and/or market release.
- Provide ongoing support to core and project teams for regulatory issues and questions. Find, interpret, and apply regulations and guidance appropriately for situations.
- Support Quality organization as necessary in audits and initiatives.
SKILLS NEEDED
- Familiarity with current regulatory thinking around software and AI medical device software development.
- Direct experience with previously demonstrated examples for generating modular submission documentation and working with various regulatory agencies (e.g. FDA, Notified Bodies).
- Strong problem-solving skills and the ability to work independently as well as collaboratively in a team environment.
- Leadership and interpersonal skills to develop and manage good working relationships within Regulatory Affairs and with other internal departments (R&D, Product, Quality etc).
- Excellent communication (written and verbal) and stakeholder management skills to facilitate collaboration across teams and external partners.
- Strong project management skills with the ability to coordinate cross-functional teams and manage multiple regulatory projects/initiatives.
EDUCATIONAL REQUIREMENTS & WORK EXPERIENCE
- Bachelor's degree in Science, Engineering, or a related field
- Minimum of 3 years of Regulatory Affairs medical device experience
- 1 year working with software as a medical device (SaMD) preferred
COMPENSATION
This position has an estimated base salary of $110,000 - $150,000 and bonus.
Heartflow is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all individuals and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination. Positions posted for Heartflow are not intended for or open to third party recruiters/agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals. Heartflow has become aware of a fraud where unknown entities are posing as Heartflow recruiters in an attempt to obtain personal information from individuals as part of our application or job offer process. Before providing any personal information to outside parties, please verify the following: A) all legitimate Heartflow recruiter email addresses end with “@heartflow.com” and B) the position described is found on our careers site at www.heartflow.com/about/careers/.
INTRODUCTION
Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product—an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis—provides a color-coded, 3D model of a patient’s coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMap™Analysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare. Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 500,000 patients worldwide.
ROLE AND RESPONSIBILITIES
The Senior Regulatory Affairs Specialist is responsible for coordinating and supporting regulatory activities pertaining to successful pre-market development, continued new market entry, and post-market activities for Heartflow products. This individual contributor role provides world-class regulatory support for Heartflow products, ensuring compliance with applicable global requirements while proactively navigating evolving regulatory landscapes. This position is responsible for activities related to regulatory approval to market Heartflow products from development to post-market surveillance. He/she will be responsible for the assessment of device changes for regulatory impact and develop strategies for submissions and maintenance of documentation within the shifting framework of regulatory requirements worldwide in an efficient manner.
Job Responsibilities:
- Regulatory Project Management
- Represent Regulatory Affairs on cross-functional teams (as necessary) to ensure regulatory alignment with business objectives and timely submissions.
- Facilitate development of global regulatory strategies for Heartflow products through interfacing with internal (product teams) and external partners (distributors, authorized representatives, international regulatory team).
- Review regulatory strategies with the RA management team to gain alignment on priorities and understanding of risks.
- Establish and maintain collaborative relationships and open communication channels with regulatory authorities and ensure all reporting requirements to external regulatory authorities are completed accurately and on time.
- Regulatory Operations and Compliance
- Maintain regulatory pre-market and post-market commitments and compliance (establishment registrations, certifications, reporting, special controls, etc) and related activities.
- Support development of SOPs and internal guidance.
- Ensure applicable regulatory requirements are considered and appropriately incorporated into projects to ensure compliance.
- Manage worldwide submissions for new products and product changes as required to ensure timely approval for clinical studies and/or market release.
- Provide ongoing support to core and project teams for regulatory issues and questions. Find, interpret, and apply regulations and guidance appropriately for situations.
- Support Quality organization as necessary in audits and initiatives.
SKILLS NEEDED
- Familiarity with current regulatory thinking around software and AI medical device software development.
- Direct experience with previously demonstrated examples for generating modular submission documentation and working with various regulatory agencies (e.g. FDA, Notified Bodies).
- Strong problem-solving skills and the ability to work independently as well as collaboratively in a team environment.
- Leadership and interpersonal skills to develop and manage good working relationships within Regulatory Affairs and with other internal departments (R&D, Product, Quality etc).
- Excellent communication (written and verbal) and stakeholder management skills to facilitate collaboration across teams and external partners.
- Strong project management skills with the ability to coordinate cross-functional teams and manage multiple regulatory projects/initiatives.
EDUCATIONAL REQUIREMENTS & WORK EXPERIENCE
- Bachelor's degree in Science, Engineering, or a related field
- Minimum of 3 years of Regulatory Affairs medical device experience
- 1 year working with software as a medical device (SaMD) preferred
COMPENSATION
This position has an estimated base salary of $110,000 - $150,000 and bonus.
Heartflow is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all individuals and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination. Positions posted for Heartflow are not intended for or open to third party recruiters/agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals. Heartflow has become aware of a fraud where unknown entities are posing as Heartflow recruiters in an attempt to obtain personal information from individuals as part of our application or job offer process. Before providing any personal information to outside parties, please verify the following: A) all legitimate Heartflow recruiter email addresses end with “@heartflow.com” and B) the position described is found on our careers site at www.heartflow.com/about/careers/.
How to Get Visa Sponsorship as a Senior Regulatory Affairs Specialist
Target FDA-regulated industries first
Pharmaceutical, biotech, and medical device companies file the highest volume of H-1B petitions for regulatory roles. These employers have established immigration programs and legal teams, making the sponsorship process faster and more predictable than smaller organizations.
Lead with your regulatory credentials
RAC certification, eCTD submission experience, or IND/NDA filing history signals specialized expertise that justifies sponsorship. Employers are far more willing to sponsor when your credentials reduce their risk of an H-1B specialty occupation challenge from USCIS.
Align your degree field to the job description
USCIS requires your degree to relate directly to the role. A chemistry, pharmacy, or biomedical engineering degree is a strong match. If your degree is in a tangentially related field, gather documentation showing how your coursework maps to regulatory functions.
Ask about sponsorship before the final interview round
Regulatory roles often have long hiring timelines. Confirming sponsorship willingness during the second round avoids wasting weeks on a process the employer won't complete. Most pharma and device companies expect international candidates and will answer directly.
Understand the H-1B cap timeline and plan accordingly
H-1B registration opens in March for an October 1 start date. If you miss the lottery, ask whether the employer can place you in a cap-exempt role or explore O-1A eligibility if you have publications, regulatory guidance contributions, or industry recognition.
Document submission experience with specific product types
510(k), PMA, BLA, and CE mark submissions are concrete proof of specialty knowledge. Quantify your experience in your resume with submission counts and product categories. This specificity helps employers justify the LCA and strengthens your H-1B petition significantly.
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Get Access To All JobsFrequently Asked Questions
Does a Senior Regulatory Affairs Specialist role qualify for H-1B sponsorship?
Yes, Senior Regulatory Affairs Specialist is a well-established H-1B specialty occupation. USCIS consistently recognizes the role as requiring at least a bachelor's degree in a specific field such as regulatory science, chemistry, biology, pharmacy, or biomedical engineering. Employers in pharma, biotech, and medical devices routinely file H-1B petitions for this title, and approval rates for specialty occupation RFEs in this category are generally favorable.
What degree do I need for a company to sponsor my visa for this role?
Most employers require a bachelor's degree or higher in a directly related field, regulatory science, chemistry, pharmaceutical sciences, biology, or biomedical engineering are the strongest matches. Some companies accept degrees in adjacent fields if your coursework or experience ties directly to regulatory functions. A general business or unrelated STEM degree alone is unlikely to satisfy USCIS specialty occupation requirements without additional documentation.
Which types of employers sponsor Senior Regulatory Affairs Specialists?
Pharmaceutical manufacturers, biotech companies, contract research organizations (CROs), and medical device firms are the most active sponsors. Large companies like Johnson & Johnson, Pfizer, Medtronic, and Abbott have high-volume immigration programs. Smaller specialty pharma and emerging biotech companies also sponsor but may have less predictable timelines. Browse open roles on Migrate Mate to find employers actively hiring with sponsorship available.
Can I qualify for an O-1A visa as a Regulatory Affairs Specialist?
Possibly, if you have a strong track record of recognized contributions. Peer-reviewed publications, presentations at major regulatory conferences, authorship of guidance documents, or membership on regulatory advisory boards can support O-1A criteria. The O-1A is harder to obtain than an H-1B for most specialists, but it is a viable alternative if you missed the H-1B lottery or work for a cap-exempt employer and want flexibility.
Does prior regulatory experience in another country count toward U.S. visa sponsorship?
Yes. USCIS considers international regulatory experience when evaluating H-1B petitions, particularly for senior-level roles. Experience with EMA submissions, Health Canada, or TGA filings demonstrates regulatory expertise directly relevant to FDA processes. Employers will typically require documentation, employment records, submission logs, or reference letters, to substantiate experience gained abroad, especially if it is being used to meet degree equivalency requirements.
What is the prevailing wage requirement for sponsored Senior Regulatory Affairs Specialist 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.
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