Senior Regulatory Affairs Specialist Jobs in USA with Visa Sponsorship
Senior Regulatory Affairs Specialists are strong candidates for H-1B visa 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 JobsAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function: Regulatory Affairs Group
Job Sub Function: Regulatory Affairs
Job Category: Professional
All Job Posting Locations: Cincinnati, Ohio, United States of America
Job Description:
About Surgery
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech.
We are searching for the best talent for a Senior Regulatory Affairs Specialist to support our active capital, energy-based business. This role will work a Flex/Hybrid schedule and be based in the Cincinnati, OH office. There is NO remote option and relocation assistance is not provided.
Purpose: The Senior Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for MedTech Surgery. The individual combines knowledge of scientific, regulatory and business issues to ensure that products meet the required legislation the United States and global health authorities. Through your engagement in this role, you will help shape the surgical field.
You will be responsible for:
- Prepare and submit regulatory documents, including applications for new product registrations and maintenance of existing registrations, to US FDA and EU Notified Bodies.
- Collaborate with global regulatory partners to drive innovation and prepare global regulatory submissions.
- Maintain device registrations and licenses throughout product lifecycle. Support product lifecycle. Evaluate proposed device changes for regulatory requirements and perform required regulatory submissions. Assist in the development of multi-country regulatory strategy.
- Monitor changes in regulations. Maintain and update strategy based upon regulatory changes in responsible jurisdictions.
- Provide regulatory support with teammates for internal and external audits (e.g. MDSAP).
Be passionate about Regulatory Affairs impact in research, development, clinical, marketing, and production of state-of-the-art medical devices.
- Able to manage multiple overlapping priorities across projects.
Qualifications / Requirements:
- Minimum of a Bachelor’s Degree required. Science or Engineering discipline highly desired.
- At least 4+ years of related professional Regulatory Affairs experience required (2+ with Advanced Degree).
- Ability to comprehend principles of engineering, physiology and medical device use.
- Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance.
- Exceptional self-education skills required, including proactive and comprehensive research of new and existing regulations, processes, and tools before requesting assistance.
- Strong verbal communication and regulatory/medical writing skills.
- Ability to effectively manage multiple projects and priorities.
- Exhibit leadership traits such as a positive, forward looking approach to problem-solving, and accountable, action-oriented approach to deliver results. Results oriented and ability to meet project schedules.
- Enjoy teamwork and thrive as a member of cross-functional teams.
- Be adaptable and thrive in a dynamic work environment where variety is the routine.
- Experience with US Class II device submissions.
- Experience with active medical devices, including software, cybersecurity and electromagnetic evaluation submissions, preferred.
- Regulatory Certification (such as RAC from the Regulatory Affairs Professionals Society) is a plus.
- Travel up to 10%.
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork
The anticipated base pay range for this position is:
$92,000.00 - $148,350.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation – 120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
Holiday pay, including Floating Holidays – 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.
LI-Hybrid
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function: Regulatory Affairs Group
Job Sub Function: Regulatory Affairs
Job Category: Professional
All Job Posting Locations: Cincinnati, Ohio, United States of America
Job Description:
About Surgery
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech.
We are searching for the best talent for a Senior Regulatory Affairs Specialist to support our active capital, energy-based business. This role will work a Flex/Hybrid schedule and be based in the Cincinnati, OH office. There is NO remote option and relocation assistance is not provided.
Purpose: The Senior Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for MedTech Surgery. The individual combines knowledge of scientific, regulatory and business issues to ensure that products meet the required legislation the United States and global health authorities. Through your engagement in this role, you will help shape the surgical field.
You will be responsible for:
- Prepare and submit regulatory documents, including applications for new product registrations and maintenance of existing registrations, to US FDA and EU Notified Bodies.
- Collaborate with global regulatory partners to drive innovation and prepare global regulatory submissions.
- Maintain device registrations and licenses throughout product lifecycle. Support product lifecycle. Evaluate proposed device changes for regulatory requirements and perform required regulatory submissions. Assist in the development of multi-country regulatory strategy.
- Monitor changes in regulations. Maintain and update strategy based upon regulatory changes in responsible jurisdictions.
- Provide regulatory support with teammates for internal and external audits (e.g. MDSAP).
Be passionate about Regulatory Affairs impact in research, development, clinical, marketing, and production of state-of-the-art medical devices.
- Able to manage multiple overlapping priorities across projects.
Qualifications / Requirements:
- Minimum of a Bachelor’s Degree required. Science or Engineering discipline highly desired.
- At least 4+ years of related professional Regulatory Affairs experience required (2+ with Advanced Degree).
- Ability to comprehend principles of engineering, physiology and medical device use.
- Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance.
- Exceptional self-education skills required, including proactive and comprehensive research of new and existing regulations, processes, and tools before requesting assistance.
- Strong verbal communication and regulatory/medical writing skills.
- Ability to effectively manage multiple projects and priorities.
- Exhibit leadership traits such as a positive, forward looking approach to problem-solving, and accountable, action-oriented approach to deliver results. Results oriented and ability to meet project schedules.
- Enjoy teamwork and thrive as a member of cross-functional teams.
- Be adaptable and thrive in a dynamic work environment where variety is the routine.
- Experience with US Class II device submissions.
- Experience with active medical devices, including software, cybersecurity and electromagnetic evaluation submissions, preferred.
- Regulatory Certification (such as RAC from the Regulatory Affairs Professionals Society) is a plus.
- Travel up to 10%.
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork
The anticipated base pay range for this position is:
$92,000.00 - $148,350.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation – 120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
Holiday pay, including Floating Holidays – 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.
LI-Hybrid
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Get Access To All JobsTips for Finding 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.
Senior Regulatory Affairs Specialist jobs are hiring across the US. Find yours.
Find Senior Regulatory Affairs Specialist 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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