Senior Regulatory Affairs Specialist Jobs in USA with Visa Sponsorship
Senior Regulatory Affairs Specialist roles qualify as specialty occupations under H-1B visa, E-3 visa, and TN visas, making them strong candidates for employer sponsorship. Life sciences, medical device, and pharmaceutical companies file LCAs regularly for this title, and a directly related degree in life sciences, chemistry, or engineering is typically required. For detailed occupation requirements, see the O*NET profile.
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Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities.
Understanding PROCEPT's Culture
At PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do, while also working together seamlessly for a common goal. At Procept, curiosity, ingenuity and conviction in the power technology will transform the lives of our patients and providers.
And this doesn’t happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procept’s history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens.
We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept, we push beyond just finding a work/life balance, we strive to find a work/life blend, a professional world that you are honored and impassioned to belong to, one that you can proudly share with your family, friends, and acquaintances.
An opportunity at PROCEPT BioRobotics won’t just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world!
The Opportunity That Awaits You
Help make our first impression the best that it can be. This role provides expert support for regulatory project management, strategic submissions, and cross-functional compliance activities in global regulated markets for product labeling activities. No product can be complete without comprehensive, clear, and compliant labels. As part of the team that ensures our labels meet the user’s needs, the Senior Regulatory Affairs Specialist (Labeling) will work closely with other departments across the organization, making this a position that offers a unique breadth of exposure to different medtech compliance and design functions. The ideal candidate is a motivated regulatory professional ready to contribute to the growth of the department while continuing to advance their own understanding of regulatory compliance, technical content creation, and product development. Succeed in this role with your attention to detail, critical thinking, initiative, and creative flair.
What Your Day-To-Day Will Involve
- Lead regulatory labeling activities in support of global regulatory submissions for product registrations and variations.
- Lead authorship responsibilities for content within User Manuals, product inserts, and on-product labeling.
- Provide SME input on global regulatory labeling requirements and standards. Apply style guidelines and branding standards to new and modified product labeling. Verify that labeling complies with all applicable requirements.
- Manage external service providers in designing graphic content for label artwork using design software, such as Adobe Illustrator, as well as dedicated labeling software, such as Bartender.
- Create and revise label items within the company’s document control system, by drafting and releasing engineering change orders.
- Contribute to Labeling department process improvement initiatives.
- Represent the Regulatory Affairs labeling function on project teams by collecting potential labeling inputs from other departments; interpreting the impact that projects, such as design changes, will have on labeling content; and implementing necessary modifications to the product labeling.
Work Arrangement: This position is predominantly remote, with occasional onsite attendance required based on business needs. Candidates must be local and able to report to the office as needed for meetings, collaboration, and other business-related activities.
The Qualifications We Need You to Possess
- Bachelor’s degree, in scientific or engineering field preferred
- Five (5)-plus years work experience in medical device field
- Minimum of 5 years’ experience working in regulatory affairs in a medical device company
- Knowledge of Title 21 of the US code of Federal Regulations (21 CFR 800-1299)
- Experience with US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k)
- Experience with European Medical Device Directive (93/42/EEC with 2007/47/EC) and EU Medical Device Regulation 2017/745
- Experience with Quality Management System Standard ISO 13485 is required
- Experience working cross-functionally with engineering, marketing, manufacturing, and legal teams to facilitate completion of labeling and artwork assignments
- Excellent written communication skills, especially with technical information
- Proficiency in Microsoft Office Suite preferred
- Precise, thorough and analytical
- Proactive and adaptable to a fast-paced work environment, including managing multiple projects simultaneously
The Qualifications We Would Like You to Possess
- Advanced degree or credential in regulatory affairs preferred
- Hands-on experience maintaining Instructions for Use (IFUs), product labels, capital equipment documentation, and packaging labels in compliance with regulatory standards and internal labeling requirements
- Experience with e-labeling applications and/or content management system applications preferred
- Fluent in graphic design software and/or desktop publishing software
Pay Range for this role:
$121,890 to $143,400
Company Overview
Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities.
Understanding PROCEPT's Culture
At PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do, while also working together seamlessly for a common goal. At Procept, curiosity, ingenuity and conviction in the power technology will transform the lives of our patients and providers.
And this doesn’t happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procept’s history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens.
We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept, we push beyond just finding a work/life balance, we strive to find a work/life blend, a professional world that you are honored and impassioned to belong to, one that you can proudly share with your family, friends, and acquaintances.
An opportunity at PROCEPT BioRobotics won’t just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world!
The Opportunity That Awaits You
Help make our first impression the best that it can be. This role provides expert support for regulatory project management, strategic submissions, and cross-functional compliance activities in global regulated markets for product labeling activities. No product can be complete without comprehensive, clear, and compliant labels. As part of the team that ensures our labels meet the user’s needs, the Senior Regulatory Affairs Specialist (Labeling) will work closely with other departments across the organization, making this a position that offers a unique breadth of exposure to different medtech compliance and design functions. The ideal candidate is a motivated regulatory professional ready to contribute to the growth of the department while continuing to advance their own understanding of regulatory compliance, technical content creation, and product development. Succeed in this role with your attention to detail, critical thinking, initiative, and creative flair.
What Your Day-To-Day Will Involve
- Lead regulatory labeling activities in support of global regulatory submissions for product registrations and variations.
- Lead authorship responsibilities for content within User Manuals, product inserts, and on-product labeling.
- Provide SME input on global regulatory labeling requirements and standards. Apply style guidelines and branding standards to new and modified product labeling. Verify that labeling complies with all applicable requirements.
- Manage external service providers in designing graphic content for label artwork using design software, such as Adobe Illustrator, as well as dedicated labeling software, such as Bartender.
- Create and revise label items within the company’s document control system, by drafting and releasing engineering change orders.
- Contribute to Labeling department process improvement initiatives.
- Represent the Regulatory Affairs labeling function on project teams by collecting potential labeling inputs from other departments; interpreting the impact that projects, such as design changes, will have on labeling content; and implementing necessary modifications to the product labeling.
Work Arrangement: This position is predominantly remote, with occasional onsite attendance required based on business needs. Candidates must be local and able to report to the office as needed for meetings, collaboration, and other business-related activities.
The Qualifications We Need You to Possess
- Bachelor’s degree, in scientific or engineering field preferred
- Five (5)-plus years work experience in medical device field
- Minimum of 5 years’ experience working in regulatory affairs in a medical device company
- Knowledge of Title 21 of the US code of Federal Regulations (21 CFR 800-1299)
- Experience with US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k)
- Experience with European Medical Device Directive (93/42/EEC with 2007/47/EC) and EU Medical Device Regulation 2017/745
- Experience with Quality Management System Standard ISO 13485 is required
- Experience working cross-functionally with engineering, marketing, manufacturing, and legal teams to facilitate completion of labeling and artwork assignments
- Excellent written communication skills, especially with technical information
- Proficiency in Microsoft Office Suite preferred
- Precise, thorough and analytical
- Proactive and adaptable to a fast-paced work environment, including managing multiple projects simultaneously
The Qualifications We Would Like You to Possess
- Advanced degree or credential in regulatory affairs preferred
- Hands-on experience maintaining Instructions for Use (IFUs), product labels, capital equipment documentation, and packaging labels in compliance with regulatory standards and internal labeling requirements
- Experience with e-labeling applications and/or content management system applications preferred
- Fluent in graphic design software and/or desktop publishing software
Pay Range for this role:
$121,890 to $143,400
See all 703+ Senior Regulatory Affairs Specialist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Senior Regulatory Affairs Specialist roles.
Get Access To All JobsTips for Finding Visa Sponsorship as a Senior Regulatory Affairs Specialist
Align your degree to regulatory science
USCIS scrutinizes whether your degree directly relates to the role. A bachelor's in life sciences, chemistry, pharmaceutical sciences, or biomedical engineering maps cleanly to regulatory affairs. A business degree alone will likely trigger an RFE.
Target FDA-regulated industries for LCA volume
Medical device, pharmaceutical, and biotech employers file the most LCAs for Regulatory Affairs Specialists. Focus your search on companies with FDA submissions pipelines, as their ongoing compliance needs make sponsorship structurally necessary, not incidental.
Search verified sponsor employers on Migrate Mate
Use Migrate Mate to find employers with confirmed LCA filing history for regulatory affairs roles, searchable by city and industry. This cuts time spent cold-applying to employers with no documented sponsorship track record.
Verify prevailing wage tier before accepting an offer
Your employer's LCA must certify wages at the DOL prevailing wage level for your location and experience tier. Cross-check the offered salary against the OFLC Wage Search using your job title and worksite ZIP code before signing anything.
Confirm TN eligibility if you hold Canadian or Mexican citizenship
Regulatory Affairs Specialists can qualify under TN status as scientists or engineers if the role and your degree align with a listed USMCA profession. TN requires no lottery and renews in three-year increments, making it faster than H-1B for eligible nationals.
Get your foreign credentials evaluated early
If you completed regulatory or scientific training outside the U.S., obtain a credential evaluation from a NACES-member organization before applying. Employers filing an H-1B petition need documentation that your foreign degree is equivalent to a U.S. bachelor's degree.
Frequently Asked Questions
Does a Senior Regulatory Affairs Specialist role qualify as a specialty occupation?
Yes. USCIS recognizes regulatory affairs roles in pharmaceutical, medical device, and biotech settings as specialty occupations because the work normally requires at least a bachelor's degree in a directly related field such as life sciences, chemistry, or engineering. Roles that accept any bachelor's degree regardless of field are harder to qualify, so the job description language matters significantly.
Which visa types can an employer use to sponsor a Senior Regulatory Affairs Specialist?
H-1B is the most common path and covers all nationalities, though it's subject to an annual cap and selection process. Australian citizens can use the E-3 visa, which has a separate cap that has never been exhausted. Canadian and Mexican nationals may qualify under TN status if the role aligns with a listed USMCA profession. EB-2 or EB-3 green card sponsorship is also available for permanent positions.
How do I find employers actively sponsoring Senior Regulatory Affairs Specialist roles?
Migrate Mate lists employers with verified LCA filing history for regulatory affairs roles, so you can browse companies that have documented sponsorship activity rather than guessing. Focusing on FDA-regulated industries such as medical devices, pharmaceuticals, and biologics gives you the highest concentration of active sponsors.
Does the employer need to file a PERM labor certification to sponsor this role?
PERM is required for most EB-2 and EB-3 employment-based green card petitions, not for H-1B, E-3, or TN status. For green card sponsorship, the employer advertises the position, documents that no qualified U.S. workers applied, and files a PERM application with the DOL. The process typically takes a year or more before the I-140 petition can be filed with USCIS.
Will a master's degree in regulatory affairs improve my sponsorship prospects?
A master's degree strengthens both the specialty occupation argument and your competitiveness for the H-1B advanced degree cap, which has a separate allocation of 20,000 slots for U.S. master's or higher degree holders. For roles where employer demand exceeds supply, a graduate degree in regulatory science, pharmaceutical sciences, or a related field can also accelerate progression to senior-level titles that command stronger sponsorship cases.
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.