H-1B Visa Regulatory Compliance Specialist Jobs
Regulatory Compliance Specialist roles qualify for H-1B visa sponsorship as specialty occupations requiring at least a bachelor's degree in law, business, finance, or a related field. Employers in pharmaceuticals, financial services, healthcare, and energy are active H-1B sponsors for this role, filing LCAs with the DOL before petitioning USCIS.
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Get Access To All JobsINTRODUCTION
At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position is responsible for leading, coordinating and performing study specific regulatory processes such as local IRB submissions in compliance with Good Clinical Practices (GCP) and all local, state, and federal laws, regulations, guidance, policy and procedure developed by Houston Methodist Research Institute Institutional Review Board (IRB), Food and Drug Administration (FDA) Code of Federal Regulations (CFR), and the International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of different therapeutic areas and phases in accordance with appropriate regulations, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes. The Sr Regulatory Compliance Specialist position maintains documentation for clinical research studies, case report forms and study and regulatory files. Under minimal supervision from the Manager or Director, this position identifies problem-solving issues of moderate to complex scope. The Sr Regulatory Compliance Specialist position contributes directly to internal departmental monitoring and research education as identified by the Manager or Director.
FLSA STATUS
Exempt
QUALIFICATIONS
Education
Bachelor’s degree or higher
Master’s degree preferred
Experience
Five years of experience in relevant research program experience
LICENSES AND CERTIFICATIONS
Required
Must have one of the following certifications: RAC - Regulatory Affairs Certifications (RAPS) or CCRC - Certified Clinical Research Coordinator (ACRP) or CCRP - Certified Clinical Research Professional (SOCRA)
SKILLS AND ABILITIES
Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through ongoing skills, competency assessments, and performance evaluations
Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security
Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles
Demonstrates expert knowledge and application of process improvement tools and techniques (statistical process control tools and team tools)
Demonstrates knowledge of regulatory and accrediting standards as they apply to performance improvement
Ability to enter and abstract data using personal computer, as well as the ability to utilize data to facilitate the improvement and change in processes
Ability to facilitate performance improvement teams, present data and promote a collaborative approach toward goal achievement
Ability to work independently and interdependently
Strong presentation skills and expertise in designing and implementing teams/educational offerings related to clinical quality
ESSENTIAL FUNCTIONS
PEOPLE ESSENTIAL FUNCTIONS
Collaborates with cross-functional teams including key study personnel. Role models strong, positive communication skills to ensure cohesive, smooth operation of the department
Assists in training regulatory personnel and others on regulatory and safety reporting regulations, processes, and procedures under the direct supervision of the Regulatory Compliance Manager (serves as a resource for regulatory information and guidance)
Develops and maintains interpersonal relationships with a wide variety of healthcare professionals and hospital leadership. Maintains credibility with IRB and other regulatory agencies, Sponsors, vendors, patients, and co-workers
Initiates improvement recommendations for department scores for employee engagement, i.e., peer-to-peer accountability
SERVICE ESSENTIAL FUNCTIONS
Serves as subject matter expert in support of department functions. Defines problems, collects data, establishes facts, and draws valid conclusions and evidence-based performance improvement via measurable results
Prepare and manage documents required to initiate investigational drugs trials. Prepares research protocols for IRB submission, submits protocol amendments, prepares renewals and necessary regulatory documents for submission to study sponsors. Submits adverse event reports, safety reports, and notifies IRB of study closures
Interfaces as needed with appropriate governmental agency on project/products as identified by the Manager. Assists in the preparation of periodic reports for FDA
Develops appropriate regulatory reports and associated documentation in accordance with SOPs and study specific processes under the direct supervision of the Regulatory Compliance Manager
QUALITY/SAFETY ESSENTIAL FUNCTIONS
Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP’s, FDA, GCP, NIH and applicable regulations. Provide routine updates and reporting to the Regulatory Compliance Manager to ensure timely communication regarding status of regulatory and/or important safety related issues
Conducts internal reviews and audits to ensure compliance of regulatory forms and associated documentation
Serves as a liaison between the institutional review committees, regulatory agencies, and the investigators to ensure that protocols are approved, and that supplementary information is provided in a timely fashion as requested
FINANCE ESSENTIAL FUNCTIONS
Utilizes resources with cost effectiveness and value creation in mind. Self-motivated to independently manage time effectively and prioritize daily tasks, assisting coworkers as needed
GROWTH/INNOVATION ESSENTIAL FUNCTIONS
Seeks opportunities to identify self-development needs and takes appropriate action. Ensures own career discussions occur with appropriate management. Completes and updates the My Development Plan on an ongoing basis.
SUPPLEMENTAL REQUIREMENTS
WORK ATTIRE
+ Uniform: No
+ Scrubs: No
+ Business professional: Yes
+ Other (department approved): No
ON-CALL
+ Note that employees may be required to be on-call during emergencies (ie. Disaster, Severe Weather Events, etc) regardless of selection below.
+ On Call No
TRAVEL
Travel specifications may vary by department
+ May require travel within the Houston Metropolitan area No
+ May require travel outside Houston Metropolitan area No
Houston Methodist is an Equal Opportunity Employer.
INTRODUCTION
At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position is responsible for leading, coordinating and performing study specific regulatory processes such as local IRB submissions in compliance with Good Clinical Practices (GCP) and all local, state, and federal laws, regulations, guidance, policy and procedure developed by Houston Methodist Research Institute Institutional Review Board (IRB), Food and Drug Administration (FDA) Code of Federal Regulations (CFR), and the International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of different therapeutic areas and phases in accordance with appropriate regulations, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes. The Sr Regulatory Compliance Specialist position maintains documentation for clinical research studies, case report forms and study and regulatory files. Under minimal supervision from the Manager or Director, this position identifies problem-solving issues of moderate to complex scope. The Sr Regulatory Compliance Specialist position contributes directly to internal departmental monitoring and research education as identified by the Manager or Director.
FLSA STATUS
Exempt
QUALIFICATIONS
Education
Bachelor’s degree or higher
Master’s degree preferred
Experience
Five years of experience in relevant research program experience
LICENSES AND CERTIFICATIONS
Required
Must have one of the following certifications: RAC - Regulatory Affairs Certifications (RAPS) or CCRC - Certified Clinical Research Coordinator (ACRP) or CCRP - Certified Clinical Research Professional (SOCRA)
SKILLS AND ABILITIES
Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through ongoing skills, competency assessments, and performance evaluations
Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security
Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles
Demonstrates expert knowledge and application of process improvement tools and techniques (statistical process control tools and team tools)
Demonstrates knowledge of regulatory and accrediting standards as they apply to performance improvement
Ability to enter and abstract data using personal computer, as well as the ability to utilize data to facilitate the improvement and change in processes
Ability to facilitate performance improvement teams, present data and promote a collaborative approach toward goal achievement
Ability to work independently and interdependently
Strong presentation skills and expertise in designing and implementing teams/educational offerings related to clinical quality
ESSENTIAL FUNCTIONS
PEOPLE ESSENTIAL FUNCTIONS
Collaborates with cross-functional teams including key study personnel. Role models strong, positive communication skills to ensure cohesive, smooth operation of the department
Assists in training regulatory personnel and others on regulatory and safety reporting regulations, processes, and procedures under the direct supervision of the Regulatory Compliance Manager (serves as a resource for regulatory information and guidance)
Develops and maintains interpersonal relationships with a wide variety of healthcare professionals and hospital leadership. Maintains credibility with IRB and other regulatory agencies, Sponsors, vendors, patients, and co-workers
Initiates improvement recommendations for department scores for employee engagement, i.e., peer-to-peer accountability
SERVICE ESSENTIAL FUNCTIONS
Serves as subject matter expert in support of department functions. Defines problems, collects data, establishes facts, and draws valid conclusions and evidence-based performance improvement via measurable results
Prepare and manage documents required to initiate investigational drugs trials. Prepares research protocols for IRB submission, submits protocol amendments, prepares renewals and necessary regulatory documents for submission to study sponsors. Submits adverse event reports, safety reports, and notifies IRB of study closures
Interfaces as needed with appropriate governmental agency on project/products as identified by the Manager. Assists in the preparation of periodic reports for FDA
Develops appropriate regulatory reports and associated documentation in accordance with SOPs and study specific processes under the direct supervision of the Regulatory Compliance Manager
QUALITY/SAFETY ESSENTIAL FUNCTIONS
Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP’s, FDA, GCP, NIH and applicable regulations. Provide routine updates and reporting to the Regulatory Compliance Manager to ensure timely communication regarding status of regulatory and/or important safety related issues
Conducts internal reviews and audits to ensure compliance of regulatory forms and associated documentation
Serves as a liaison between the institutional review committees, regulatory agencies, and the investigators to ensure that protocols are approved, and that supplementary information is provided in a timely fashion as requested
FINANCE ESSENTIAL FUNCTIONS
Utilizes resources with cost effectiveness and value creation in mind. Self-motivated to independently manage time effectively and prioritize daily tasks, assisting coworkers as needed
GROWTH/INNOVATION ESSENTIAL FUNCTIONS
Seeks opportunities to identify self-development needs and takes appropriate action. Ensures own career discussions occur with appropriate management. Completes and updates the My Development Plan on an ongoing basis.
SUPPLEMENTAL REQUIREMENTS
WORK ATTIRE
+ Uniform: No
+ Scrubs: No
+ Business professional: Yes
+ Other (department approved): No
ON-CALL
+ Note that employees may be required to be on-call during emergencies (ie. Disaster, Severe Weather Events, etc) regardless of selection below.
+ On Call No
TRAVEL
Travel specifications may vary by department
+ May require travel within the Houston Metropolitan area No
+ May require travel outside Houston Metropolitan area No
Houston Methodist is an Equal Opportunity Employer.
See all 117+ H-1B Visa Regulatory Compliance Specialist Jobs
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Regulatory Compliance Specialist
Align your degree to the role
USCIS scrutinizes whether your degree directly relates to compliance work. A degree in law, accounting, or business administration supports the specialty occupation argument more clearly than a general management degree, so frame your credentials accordingly in your resume and any employer petition materials.
Target industries with dense H-1B filing history
Pharmaceuticals, banking, insurance, and medical device companies file H-1B petitions for Regulatory Compliance Specialists far more consistently than general staffing firms. Use Migrate Mate to filter for employers with verified LCA filing history in your specific compliance discipline before applying.
Check the prevailing wage before negotiating
Your employer must certify your salary meets the DOL prevailing wage for your location and role. Look up the current wage level for Compliance Officers using the OFLC Wage Search before your offer conversation so you can confirm their number meets the legal threshold.
Verify the employer's SOC code assignment
Employers often classify Regulatory Compliance Specialists under different Standard Occupational Classification codes, which affects the prevailing wage calculation and LCA defensibility. Review your offer letter's job description against the O*NET profile for Compliance Officers to confirm the SOC code is accurate before the LCA is filed.
File during the cap period with a clean specialty occupation argument
Compliance roles sometimes attract USCIS Requests for Evidence challenging specialty occupation status if the job description is too broad. Ask your employer to include specific regulatory frameworks, agency reporting obligations, and degree requirements in the I-129 petition to pre-empt that challenge.
Use your 60-day grace period strategically if changing employers
If your current H-1B employer terminates your role, USCIS allows a 60-day grace period to find a new sponsor. A new employer can file an H-1B transfer petition using the same cap-exempt slot, so prioritize compliance-focused employers who can move quickly on the paperwork.
H-1B Visa Regulatory Compliance Specialist: Frequently Asked Questions
Does a Regulatory Compliance Specialist role qualify as a specialty occupation for H-1B purposes?
Yes, provided the employer documents that the role requires at least a bachelor's degree in a specific field such as law, accounting, finance, or a directly related discipline. Compliance roles that span multiple unrelated fields or accept any degree can draw USCIS scrutiny. The stronger the connection between the specific regulatory domain and a defined academic field, the lower the risk of a Request for Evidence.
Which industries sponsor H-1B visas most consistently for this role?
Pharmaceuticals, financial services, healthcare systems, medical device companies, and energy utilities sponsor H-1B petitions for Regulatory Compliance Specialists with the most frequency. These industries operate under dense federal regulatory frameworks, which makes the specialty occupation argument easier to support. You can browse verified sponsoring employers in these sectors on Migrate Mate.
Can my employer file an H-1B transfer if I'm already in H-1B status at another company?
Yes. An H-1B transfer, formally called a portability filing, lets a new employer file a new I-129 petition while you continue working. As long as the new petition is filed before your current status expires and the new role also qualifies as a specialty occupation, you can start working for the new employer once USCIS receives the petition, without waiting for approval.
How does the DOL's prevailing wage requirement affect compliance job offers?
Your employer must file a Labor Condition Application certifying your salary meets the DOL prevailing wage for your specific role, location, and experience level before USCIS will approve the H-1B petition. Compliance roles span multiple wage levels depending on seniority, so confirm which wage level your employer is using. You can verify the applicable wage using the OFLC Wage Search before accepting an offer.
What happens to my H-1B status if my compliance role is reclassified or my job duties change significantly?
A material change in job duties, location, or level of responsibility may require your employer to file an amended I-129 petition with USCIS before the change takes effect. Regulatory compliance roles that shift from advisory to supervisory functions, or move to a different metropolitan area, typically trigger an amendment obligation. Failing to amend can affect your status and create complications at future visa renewals or adjustment of status filings.