Regulatory Affairs Jobs in USA with Visa Sponsorship
Regulatory affairs is a strong field for visa sponsorship, particularly through H-1B visas, because the role clearly requires specialized knowledge in science, law, or a related field. Pharmaceutical companies, biotech firms, and medical device manufacturers regularly sponsor regulatory affairs professionals. This is one of the more straightforward specialty occupation arguments you can make, and salaries in this field typically exceed H-1B visa wage requirements comfortably. For detailed occupation requirements, see the O*NET profile.
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Amazon Devices and Services is an innovative research and development company that designs and engineers high-profile consumer electronics. We are known for creating the Kindle family of products, and devices like Fire tablets, Fire TV and Echo Frames. Working as part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to build best in class products.
The ideal candidate will have experience building a regulatory strategy and supporting documents from scratch, including developing, leading, and driving proactive execution of a global regulatory strategy. They must enjoy problem solving and possess practical hands-on knowledge of FDA submissions and reporting requirements across the product lifecycle for medical products.
Key job responsibilities
- Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements.
- Develops global regulatory strategies for new and modified products.
- Prepares and submits regulatory submissions to health agencies.
- Interprets new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures.
- Provides regulatory assessment for manufacturing, design changes and product risk assessment.
- Reviews and advises on labeling, product claims, marketing brochures, advertising and promotional material and other publications to ensure compliance with regulations.
- Plans, schedules, and arranges all activities to support regulatory timelines.
- Partners with quality system leadership to maintain regulatory and quality compliance requirements, including support during regulatory audits.
- Maintains annual licenses, registrations, and listing information. Assists with compliance to product post-marketing approval requirements.
- Supports the product release process.
- Acts as an SME for internal and external audits and inspections by internal teams or external regulatory authorities.
- Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, company policies, and governing procedures and processes.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Reviews protocols and reports to support regulatory submissions.
- Creates, reviews and approves engineering change requests.
- Acts as liaison between the Company and the various regulatory agencies. Interfaces directly with FDA and Notified Bodies.
- Provide interpretation of regulatory authorities’ feedback, policies and guidelines.
- Critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills as evidenced by past performance on drug development project teams.
About the team
The Quality & Lean, Medical Devices Operational Compliance Center (MD-OCC), consists of business process analysts, quality system experts, program managers, supply chain experts, regulatory experts, clinical affairs, and internal auditors. Our mission is to establish and manage Amazon Devices and Services Medical Product Quality and Regulatory Systems; enabling the manufacture and distribution of safe, effective and high-quality medical products for at home, mobile health and wellness customers.
BASIC QUALIFICATIONS
- 7+ years of working directly with engineering teams experience
- 5+ years of technical product or program management experience
- 5+ years of technical program management working directly with software engineering teams experience
- Experience managing programs across cross functional teams, building processes and coordinating release schedules
- Experience with regulatory filings and reports or equivalent
- Experience that includes strong analytical skills, attention to detail, and effective communication abilities, or experience working with customers with a passion for delivering exceptional service
- Experience working on multi-team, cross-disciplinary projects
- Experience that includes strong analytical skills, attention to detail, and effective communication abilities
- Experience in identifying incomplete or inaccurate data, identifying the root cause and creating/implementing an escalation plan, or experience communicating results to senior leadership
- Bachelor’s Degree in Scientific discipline e.g. Biomedical Engineering, life Sciences, Biology (or equivalent qualifications)
- 5 years of experience working within the requirements of 21 CFR 820, ISO13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).
- 5 years of experience in a regulated industry with experience working with Class II and/or Class III devices.
- Knowledge and understanding of guiding principles in device development such as benefit/risk profile, statistical design or drug dose selection
- Experience with medical device software requirements.
PREFERRED QUALIFICATIONS
- 5+ years of project management disciplines including scope, schedule, budget, quality, along with risk and critical path management experience
- Experience managing projects across cross functional teams, building sustainable processes and coordinating release schedules
- Experience defining KPI's/SLA's used to drive multi-million dollar businesses and reporting to senior leadership
- Experience working with Data & AI related technologies, including, but not limited to, AI/ML, GenAI, Analytics, Database, and/or Storage
- Regulatory Affairs Certification (RAPS)
Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status.
Los Angeles County applicants: Job duties for this position include: work safely and cooperatively with other employees, supervisors, and staff; adhere to standards of excellence despite stressful conditions; communicate effectively and respectfully with employees, supervisors, and staff to ensure exceptional customer service; and follow all federal, state, and local laws and Company policies. Criminal history may have a direct, adverse, and negative relationship with some of the material job duties of this position. These include the duties and responsibilities listed above, as well as the abilities to adhere to company policies, exercise sound judgment, effectively manage stress and work safely and respectfully with others, exhibit trustworthiness and professionalism, and safeguard business operations and the Company’s reputation. Pursuant to the Los Angeles County Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.
Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit https://amazon.jobs/content/en/how-we-hire/accommodations for more information. If the country/region you’re applying in isn’t listed, please contact your Recruiting Partner.
The base salary range for this position is listed below. Your Amazon package will include sign-on payments and restricted stock units (RSUs). Final compensation will be determined based on factors including experience, qualifications, and location. Amazon also offers comprehensive benefits including health insurance (medical, dental, vision, prescription, Basic Life & AD&D insurance and option for Supplemental life plans, EAP, Mental Health Support, Medical Advice Line, Flexible Spending Accounts, Adoption and Surrogacy Reimbursement coverage), 401(k) matching, paid time off, and parental leave. Learn more about our benefits at https://amazon.jobs/en/benefits.
LOCATION
USA, WA, Bellevue
COMPENSATION
- Salary Range: $148,700.00 - $201,200.00 USD annually
DESCRIPTION
Amazon Devices and Services is an innovative research and development company that designs and engineers high-profile consumer electronics. We are known for creating the Kindle family of products, and devices like Fire tablets, Fire TV and Echo Frames. Working as part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to build best in class products.
The ideal candidate will have experience building a regulatory strategy and supporting documents from scratch, including developing, leading, and driving proactive execution of a global regulatory strategy. They must enjoy problem solving and possess practical hands-on knowledge of FDA submissions and reporting requirements across the product lifecycle for medical products.
Key job responsibilities
- Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements.
- Develops global regulatory strategies for new and modified products.
- Prepares and submits regulatory submissions to health agencies.
- Interprets new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures.
- Provides regulatory assessment for manufacturing, design changes and product risk assessment.
- Reviews and advises on labeling, product claims, marketing brochures, advertising and promotional material and other publications to ensure compliance with regulations.
- Plans, schedules, and arranges all activities to support regulatory timelines.
- Partners with quality system leadership to maintain regulatory and quality compliance requirements, including support during regulatory audits.
- Maintains annual licenses, registrations, and listing information. Assists with compliance to product post-marketing approval requirements.
- Supports the product release process.
- Acts as an SME for internal and external audits and inspections by internal teams or external regulatory authorities.
- Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, company policies, and governing procedures and processes.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Reviews protocols and reports to support regulatory submissions.
- Creates, reviews and approves engineering change requests.
- Acts as liaison between the Company and the various regulatory agencies. Interfaces directly with FDA and Notified Bodies.
- Provide interpretation of regulatory authorities’ feedback, policies and guidelines.
- Critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills as evidenced by past performance on drug development project teams.
About the team
The Quality & Lean, Medical Devices Operational Compliance Center (MD-OCC), consists of business process analysts, quality system experts, program managers, supply chain experts, regulatory experts, clinical affairs, and internal auditors. Our mission is to establish and manage Amazon Devices and Services Medical Product Quality and Regulatory Systems; enabling the manufacture and distribution of safe, effective and high-quality medical products for at home, mobile health and wellness customers.
BASIC QUALIFICATIONS
- 7+ years of working directly with engineering teams experience
- 5+ years of technical product or program management experience
- 5+ years of technical program management working directly with software engineering teams experience
- Experience managing programs across cross functional teams, building processes and coordinating release schedules
- Experience with regulatory filings and reports or equivalent
- Experience that includes strong analytical skills, attention to detail, and effective communication abilities, or experience working with customers with a passion for delivering exceptional service
- Experience working on multi-team, cross-disciplinary projects
- Experience that includes strong analytical skills, attention to detail, and effective communication abilities
- Experience in identifying incomplete or inaccurate data, identifying the root cause and creating/implementing an escalation plan, or experience communicating results to senior leadership
- Bachelor’s Degree in Scientific discipline e.g. Biomedical Engineering, life Sciences, Biology (or equivalent qualifications)
- 5 years of experience working within the requirements of 21 CFR 820, ISO13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).
- 5 years of experience in a regulated industry with experience working with Class II and/or Class III devices.
- Knowledge and understanding of guiding principles in device development such as benefit/risk profile, statistical design or drug dose selection
- Experience with medical device software requirements.
PREFERRED QUALIFICATIONS
- 5+ years of project management disciplines including scope, schedule, budget, quality, along with risk and critical path management experience
- Experience managing projects across cross functional teams, building sustainable processes and coordinating release schedules
- Experience defining KPI's/SLA's used to drive multi-million dollar businesses and reporting to senior leadership
- Experience working with Data & AI related technologies, including, but not limited to, AI/ML, GenAI, Analytics, Database, and/or Storage
- Regulatory Affairs Certification (RAPS)
Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status.
Los Angeles County applicants: Job duties for this position include: work safely and cooperatively with other employees, supervisors, and staff; adhere to standards of excellence despite stressful conditions; communicate effectively and respectfully with employees, supervisors, and staff to ensure exceptional customer service; and follow all federal, state, and local laws and Company policies. Criminal history may have a direct, adverse, and negative relationship with some of the material job duties of this position. These include the duties and responsibilities listed above, as well as the abilities to adhere to company policies, exercise sound judgment, effectively manage stress and work safely and respectfully with others, exhibit trustworthiness and professionalism, and safeguard business operations and the Company’s reputation. Pursuant to the Los Angeles County Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.
Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit https://amazon.jobs/content/en/how-we-hire/accommodations for more information. If the country/region you’re applying in isn’t listed, please contact your Recruiting Partner.
The base salary range for this position is listed below. Your Amazon package will include sign-on payments and restricted stock units (RSUs). Final compensation will be determined based on factors including experience, qualifications, and location. Amazon also offers comprehensive benefits including health insurance (medical, dental, vision, prescription, Basic Life & AD&D insurance and option for Supplemental life plans, EAP, Mental Health Support, Medical Advice Line, Flexible Spending Accounts, Adoption and Surrogacy Reimbursement coverage), 401(k) matching, paid time off, and parental leave. Learn more about our benefits at https://amazon.jobs/en/benefits.
LOCATION
USA, WA, Bellevue
COMPENSATION
- Salary Range: $148,700.00 - $201,200.00 USD annually
See all 1,213+ Regulatory Affairs Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Regulatory Affairs roles.
Get Access To All JobsTips for Finding Regulatory Affairs Jobs
Earn the RAC credential from RAPS
The Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society is the gold standard in the field. Available in three specializations - drugs, devices, and biologics - RAC demonstrates comprehensive knowledge of U.S. and international regulatory frameworks. Holding this credential strengthens both your job competitiveness and the employer's H-1B specialty occupation argument.
Target the Boston-Cambridge and San Francisco biotech hubs
The largest concentrations of pharma and biotech companies are in the Boston-Cambridge corridor and the San Francisco Bay Area, including South San Francisco. Companies in these hubs compete intensely for regulatory affairs talent and are experienced with H-1B sponsorship. The New Jersey pharmaceutical corridor around Princeton and New Brunswick is another major cluster.
Specialize in biologics or combination device regulation
Regulatory professionals with expertise in biologics (BLA submissions), biosimilars (351(k) pathway), or combination products face less competition than those in traditional small-molecule drug regulation. The FDA's regulatory framework for biologics and combination devices is complex and evolving, creating sustained demand for specialists. This specialization can differentiate you from a larger pool of general regulatory affairs candidates.
Leverage international regulatory experience as a global asset
Pharmaceutical companies filing regulatory submissions across multiple markets need professionals who understand EMA, PMDA, TGA, Health Canada, and other regulatory agencies alongside the FDA. If you have experience preparing submissions for non-U.S. regulatory bodies, position this as a strategic asset for global regulatory strategy. Companies pursuing simultaneous multi-market approvals value this cross-border expertise.
Frequently Asked Questions
Do pharmaceutical and biotech companies sponsor regulatory affairs professionals?
Yes, regulatory affairs is a specialized field with strong H-1B visa sponsorship demand across pharma, biotech, and medical device companies. Positions typically require a bachelor's or master's degree in life sciences, pharmacy, or a related field, plus knowledge of FDA regulations. Companies like Pfizer, Johnson and Johnson, Roche, AbbVie, Merck, and Medtronic regularly sponsor regulatory affairs specialists and managers.
What makes regulatory affairs a strong field for visa sponsorship?
Regulatory affairs professionals possess specialized knowledge of FDA submission processes (510(k), PMA, NDA, BLA, ANDA), international regulatory frameworks, and clinical development regulations. This expertise is difficult to replace and clearly meets the H-1B specialty occupation standard. The field has a relatively small talent pool compared to demand, particularly for professionals experienced with complex biological products or combination devices.
What degree is needed for regulatory affairs visa sponsorship?
A bachelor's degree in a life science (biology, chemistry, pharmacy, biomedical engineering) is the minimum, and many roles prefer or require a master's degree. Some universities offer specialized Master of Science in Regulatory Affairs or Regulatory Science programs - Johns Hopkins, Northeastern, and University of Southern California are among them. A Regulatory Affairs Certification (RAC) from RAPS further strengthens your credentials.
How to find Regulatory Affairs jobs with visa sponsorship?
To find Regulatory Affairs jobs with visa sponsorship, use Migrate Mate, which specializes in connecting international professionals with sponsoring employers. Focus on pharmaceutical companies, medical device manufacturers, biotechnology firms, and healthcare organizations that frequently sponsor H-1B, L-1 visa, and other work visas for regulatory professionals. These industries regularly need qualified candidates to navigate complex compliance requirements and often sponsor international talent.
Can regulatory affairs experience from outside the U.S. count toward a visa petition?
Yes, experience with international regulatory agencies - EMA (Europe), PMDA (Japan), TGA (Australia), Health Canada, or NMPA (China) - is valuable and can support your H-1B petition. Many pharmaceutical companies need professionals who understand both FDA and international regulatory pathways for global submissions. This cross-border expertise makes you more valuable to multinational employers.
What is the prevailing wage requirement for sponsored Regulatory Affairs jobs?
When a U.S. employer sponsors a foreign worker for a work visa, they are legally required to pay at least the "prevailing wage" — the average wage paid to workers in the same occupation, in the same geographic area, with similar experience. This is set by the Department of Labor to prevent employers from hiring foreign workers at below-market rates. The prevailing wage varies significantly by role, location, and experience level — for example, a regulatory affairs in California will have a different prevailing wage than the same role in a smaller state. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search.