H-1B Visa Senior Regulatory Affairs Specialist Jobs
Senior Regulatory Affairs Specialists qualify for H-1B visa sponsorship as a specialty occupation requiring a bachelor's degree or higher in a directly related scientific or technical field. Pharmaceutical, biotech, and medical device companies are the most consistent H-1B filers for this role, with LCA filings concentrated in New Jersey, California, and Massachusetts.
Find H-1B Visa Senior Regulatory Affairs Specialist JobsOverview
Showing 5 of 28+ Senior Regulatory Affairs Specialist jobs
See all 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 JobsCompany 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
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 H-1B Visa Senior Regulatory Affairs Specialist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Senior Regulatory Affairs Specialist Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Senior Regulatory Affairs Specialist
Align your degree to SOC codes
USCIS evaluates specialty occupation based on whether your degree field directly relates to the role. Check the O*NET profile for Regulatory Affairs Specialists to confirm which degree fields map cleanly to this SOC code before applying.
Target LCA-active pharmaceutical employers
Search Migrate Mate to filter for employers with verified LCA filings for Regulatory Affairs roles. Companies actively filing Labor Condition Applications have already cleared the DOL certification step and are structurally set up to sponsor.
Document your regulatory submissions portfolio
Compile a record of FDA submissions, dossiers, or health authority interactions you've led. Employers use this documentation to build the specialty occupation justification in your I-129 petition, so specificity about submission types and therapeutic areas strengthens the filing.
Clarify the prevailing wage level early
Use the OFLC Wage Search to look up the prevailing wage for your target job title, SOC code, and metro area before negotiating an offer. Your offered salary must meet or exceed the DOL wage level the employer certifies on the LCA.
Confirm cap-subject status before your H-1B start date
Regulatory roles at biotech startups and most pharma companies are cap-subject, meaning you'll need to register in the annual lottery. Roles at nonprofit research hospitals or FDA-funded academic medical centers may qualify as cap-exempt, which changes your timeline entirely.
Address degree equivalency for three-year credentials
If you hold a three-year bachelor's degree, your employer's attorney will need a credential evaluation and possibly a professional opinion letter to establish equivalency to a U.S. four-year degree. Request this evaluation early so it's ready when the I-129 is filed.
H-1B Visa Senior Regulatory Affairs Specialist: Frequently Asked Questions
Does a Senior Regulatory Affairs Specialist role qualify as a specialty occupation for H-1B purposes?
Yes. USCIS treats Regulatory Affairs Specialist positions as specialty occupations because they typically require a bachelor's degree or higher in a directly related field such as life sciences, pharmacy, chemistry, or biomedical engineering. Employers strengthen the petition by documenting that the specific role requires this degree, not just that candidates often hold one.
Which industries sponsor H-1B visas most consistently for this role?
Pharmaceutical manufacturers, biotechnology companies, and medical device firms account for the large majority of H-1B LCA filings for Regulatory Affairs roles. Contract research organizations and clinical-stage startups also file regularly. You can browse employers with verified LCA filing history for this occupation on Migrate Mate before you apply.
How does the H-1B lottery affect my job search timeline as a regulatory professional?
Cap-subject H-1B registrations are submitted in March for an October 1 start date. If you're currently on OPT or STEM OPT, you need an employer to register you during that window. Roles at qualifying nonprofit research institutions or government research entities may be cap-exempt, allowing filing year-round without a lottery slot.
What happens to my H-1B status if I move from one regulatory role to another employer?
H-1B portability under AC21 lets you start with a new employer once you've filed a new I-129 petition, as long as your original petition has been approved and you've been in valid H-1B status for at least 180 days. Your new employer must file before your current status expires, and the new role must remain in the same or a substantially similar specialty occupation.
Can my employer sponsor me for a green card while I'm on H-1B in a regulatory affairs role?
Yes. Most employer-sponsored green card paths for Regulatory Affairs Specialists go through the PERM labor certification process, which requires the employer to test the labor market before filing. EB-2 or EB-3 classification applies depending on the degree requirement attached to the role. You can remain in H-1B status throughout the PERM and I-140 stages.