J-1 Visa Senior Regulatory Affairs Specialist Jobs
Senior Regulatory Affairs Specialist roles in the United States are typically available to qualified professionals through the J-1 Specialist or Trainee program category, depending on your experience level. Finding a host employer willing to work with a designated J-1 sponsorship organization is the key step before any DS-2019 can be issued.
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Get Access To All JobsINTRODUCTION
At Alamar, we are passionate about enabling our customers to make scientific discoveries that translate into clinical outcomes and benefit patients. Our team is growing quickly as we develop innovative approaches to measure critical protein biomarkers from liquid samples that can enable the earliest possible detection of disease. We believe the next frontier in biology is enabled by measuring proteins at higher sensitivity in highly multiplexed assays at the push of a button, which is something only Alamar can do. As we build our team, we seek collaborative, driven, intellectually curious people committed to solving complex challenges. Our culture rewards accountability and cross-functional teamwork because we believe this enables the kind of breakthrough thinking that will accelerate our mission.
We are seeking a detail-oriented and experienced Senior QA/Verification Specialist to join our team. In this role, you will be responsible for ensuring the quality, reliability, and regulatory compliance of our software products. You will design and execute comprehensive test cases, and develop FDA-compliant documentation in support of our product submissions and quality management system.
KEY RESPONSIBILITIES
- Plan, design, and execute functional, integration, regression, and system-level software tests across multiple product releases.
- Author and maintain detailed software test cases, test plans, and test reports in accordance with internal standards and regulatory requirements.
- Review, and maintain FDA-required software documentation, including Software Requirements Specifications (SRS), Software Design Specifications (SDS), Hazard Analysis, Traceability Matrices, and Verification & Validation (V&V) protocols and reports.
- Ensure documentation aligns with FDA guidance, including 21 CFR Part 11, 21 CFR Part 820, IEC 62304, and relevant ISO standards.
- Collaborate with software developers, product managers, and regulatory affairs teams to define acceptance criteria and quality benchmarks.
- Identify, document, and track software defects through resolution using issue tracking tools.
- Participate in design reviews and risk analysis activities.
- Support internal audits, external audits, and FDA inspections by ensuring documentation is accurate, complete, and audit-ready.
- Contribute to continuous improvement of QA processes, tools, and documentation templates.
REQUIRED QUALIFICATIONS
- Bachelor's degree in Science or Engineering.
- 6+ years of experience in quality assurance, preferably in a regulated industry (medical device, pharmaceutical, or life sciences).
- Demonstrated experience writing and executing test cases and test plans.
- Hands-on experience maintaining FDA regulatory documentation (e.g., 510(k)).
- Understanding of FDA guidance documents, such as:
+ Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- Familiarity with risk management frameworks such as ISO 14971.
- Proficiency with defect tracking and project management tools.
- Strong written communication skills with meticulous attention to detail.
COMPENSATION
- The base salary range for this full-time position is $120,000 - $140,000 + bonus + equity + benefits.
- Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process.
INTRODUCTION
At Alamar, we are passionate about enabling our customers to make scientific discoveries that translate into clinical outcomes and benefit patients. Our team is growing quickly as we develop innovative approaches to measure critical protein biomarkers from liquid samples that can enable the earliest possible detection of disease. We believe the next frontier in biology is enabled by measuring proteins at higher sensitivity in highly multiplexed assays at the push of a button, which is something only Alamar can do. As we build our team, we seek collaborative, driven, intellectually curious people committed to solving complex challenges. Our culture rewards accountability and cross-functional teamwork because we believe this enables the kind of breakthrough thinking that will accelerate our mission.
We are seeking a detail-oriented and experienced Senior QA/Verification Specialist to join our team. In this role, you will be responsible for ensuring the quality, reliability, and regulatory compliance of our software products. You will design and execute comprehensive test cases, and develop FDA-compliant documentation in support of our product submissions and quality management system.
KEY RESPONSIBILITIES
- Plan, design, and execute functional, integration, regression, and system-level software tests across multiple product releases.
- Author and maintain detailed software test cases, test plans, and test reports in accordance with internal standards and regulatory requirements.
- Review, and maintain FDA-required software documentation, including Software Requirements Specifications (SRS), Software Design Specifications (SDS), Hazard Analysis, Traceability Matrices, and Verification & Validation (V&V) protocols and reports.
- Ensure documentation aligns with FDA guidance, including 21 CFR Part 11, 21 CFR Part 820, IEC 62304, and relevant ISO standards.
- Collaborate with software developers, product managers, and regulatory affairs teams to define acceptance criteria and quality benchmarks.
- Identify, document, and track software defects through resolution using issue tracking tools.
- Participate in design reviews and risk analysis activities.
- Support internal audits, external audits, and FDA inspections by ensuring documentation is accurate, complete, and audit-ready.
- Contribute to continuous improvement of QA processes, tools, and documentation templates.
REQUIRED QUALIFICATIONS
- Bachelor's degree in Science or Engineering.
- 6+ years of experience in quality assurance, preferably in a regulated industry (medical device, pharmaceutical, or life sciences).
- Demonstrated experience writing and executing test cases and test plans.
- Hands-on experience maintaining FDA regulatory documentation (e.g., 510(k)).
- Understanding of FDA guidance documents, such as:
+ Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- Familiarity with risk management frameworks such as ISO 14971.
- Proficiency with defect tracking and project management tools.
- Strong written communication skills with meticulous attention to detail.
COMPENSATION
- The base salary range for this full-time position is $120,000 - $140,000 + bonus + equity + benefits.
- Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process.
See all 107+ Senior Regulatory Affairs Specialist jobs
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Get Access To All JobsTips for Finding J-1 Visa Sponsorship as a Senior Regulatory Affairs Specialist
Align your credentials to specialty occupation standards
Regulatory affairs work sits at the intersection of science and compliance. Before outreach, verify your degree field maps to the role using O*NET occupation data for Regulatory Affairs Specialists, since a misaligned credential is the fastest way to lose a host employer's interest.
Target host employers with regulatory infrastructure
Pharmaceutical, biotech, and medical device companies with in-house regulatory departments are far more likely to host J-1 Specialist or Trainee participants than generalist firms. Search for roles at companies with active FDA submission teams or global regulatory functions using Migrate Mate to filter for J-1-aligned positions.
Distinguish Trainee from Specialist category early
If you have fewer than five years of post-degree regulatory experience, the J-1 Trainee category applies. The Specialist category requires substantially more expertise. Getting this wrong delays your DS-2019, so confirm the correct category with your designated sponsor before your host employer drafts any training plan.
Build a training plan tied to regulatory milestones
Designated sponsors like Cultural Vistas or AIPT require a detailed training plan, not a job description. Map specific learning objectives to FDA, ICH, or EMA regulatory frameworks your host employer operates under, so the plan demonstrates structured knowledge transfer rather than routine employment.
Check whether your home country triggers the two-year rule
Regulatory affairs professionals from countries on the Exchange Visitor Skills List may face a two-year home residency requirement after their J-1 program ends. This affects your ability to change to H-1B or get a green card. Confirm your country's status with your designated sponsor before accepting any host offer.
Confirm your host employer's willingness to coordinate with a sponsor
Many U.S. employers conflate J-1 with direct employer-sponsored visas. During the offer stage, clarify that a designated sponsor organization issues the DS-2019 and monitors your program. Employers who understand this split structure close the process faster and with fewer compliance delays.
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Find Senior Regulatory Affairs Specialist JobsSenior Regulatory Affairs Specialist J-1 Visa: Frequently Asked Questions
Which J-1 program category applies to Senior Regulatory Affairs Specialist roles?
Most experienced regulatory affairs professionals qualify under the J-1 Specialist category, which is designed for individuals with specialized knowledge not widely available in the United States. If you have fewer than five years of relevant post-degree experience, the Trainee category may apply instead. Your designated sponsor organization makes the final determination based on your credentials, proposed training objectives, and host employer's program design.
Who actually sponsors the J-1 visa for a regulatory affairs role, and what does the host employer do?
The J-1 visa sponsor is a U.S. Department of State-designated organization, such as Cultural Vistas or AIPT, that issues your DS-2019 form and monitors program compliance. The hiring company is your host employer, not your visa sponsor. The host provides the work environment and training structure, but the designated sponsor holds legal responsibility for your exchange visitor program and must approve your training plan before you begin.
How do I find U.S. employers willing to host a J-1 regulatory affairs professional?
Regulatory affairs roles with J-1 hosting potential are concentrated in pharmaceutical, biotech, and medical device companies with established regulatory teams. Many of these employers don't advertise J-1 compatibility directly, so using Migrate Mate to search for roles aligned with J-1 sponsorship requirements saves significant time over filtering general job boards manually.
Does the two-year home residency requirement affect regulatory affairs J-1 participants?
It depends on your country of citizenship and whether your home government funded your exchange program or whether your occupation appears on the Exchange Visitor Skills List maintained by the State Department. Regulatory affairs is a technically specialized field, and some nationalities trigger the requirement automatically. If the two-year rule applies, you cannot change to H-1B or apply for a green card without first obtaining a waiver or completing the home residency period.
What should the training plan include for a J-1 Specialist in regulatory affairs?
The training plan must detail specific regulatory competencies you'll develop, not just job duties. For regulatory affairs, that means naming the specific frameworks involved, such as FDA 21 CFR submissions, ICH guidelines, or post-market surveillance protocols, and the learning milestones at each phase. Designated sponsors require this level of specificity to approve the program, and a vague plan tied to general job functions is the most common reason for delays in DS-2019 issuance.
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