OPT Regulatory Affairs Manager Jobs
Regulatory Affairs Manager jobs on OPT require employers to sponsor work authorization before your OPT period ends. Most roles sit inside pharma, biotech, or medical device companies and expect a degree in life sciences, chemistry, or a related field. STEM OPT extension eligibility is common for this role.
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Summary:
The Program Manager Health Plans Regulatory Affairs role is to assist in the implementation and maintenance of the CHRISTUS Health Compliance Program. This job assists the Regulatory Affairs team in the execution of established work priorities and plans, management, and monitoring of operational compliance related tasks. These tasks are to include internal auditing and monitoring activities, external audit coordination, and regulatory training and education.
Responsibilities:
- Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of Leaders.
- Review and research laws and regulations both on a reactive and proactive basis to ensure an effective and accurate response to legal and regulatory compliance for Medicare Advantage and Health Exchange lines of business.
- Monitors Health Plan progress in resolution of issues identified through the Risk Assessment and Monitoring Work Plan and internal and external audit findings.
- Analyze and periodically report on risk-related trends to the Compliance Committee to ensure organizational awareness of potential noncompliance.
- Perform ongoing internal monitoring/audits based on risk level.
- Support implementation of consistent processes to enhance compliance within day-to-day health plan operations.
- Provide specialized education and development of materials as requested.
- Follow up with Action items necessary related to various audit requests and compliance related issues.
- Work with the regulatory affairs team to develop streamlined approaches between lines of business.
- Cross-train the regulatory affairs team on compliance related tasks to ensure operational compliance goals are met.
- Excellent interpersonal skills with regular interaction and communication with the Senior Leadership team and other associates within the organization.
- Ability to facilitate the resolution of issues and concerns that create barriers to a high-performing team and work environment.
- Ability to manage project/monitoring work plans for achieving project goals and objectives.
- Coordinates assigned projects, including monitoring projects to present to leadership and regulatory bodies.
- Serves as Project Manager on external compliance audits conducted by regulatory bodies.
- Serves as a resource in regulatory guidance for Health Exchange and Medicare Lines of Business.
- Performs other duties as assigned.
Job Requirements:
Education/Skills
- Bachelor's Degree in Related Field of Study and or equivalent years of work experience required
Experience
- 4 - 6 years of related experience preferred
Licenses, Registrations, or Certifications
- None required
In accordance with the CHRISTUS Health License, Certification and Registration Verification Policy, all Associates are required to obtain the required certifications for their respective positions within the designated time frame.
Work Schedule:
8AM - 5PM Monday-Friday
Work Type:
Full Time
Description
Summary:
The Program Manager Health Plans Regulatory Affairs role is to assist in the implementation and maintenance of the CHRISTUS Health Compliance Program. This job assists the Regulatory Affairs team in the execution of established work priorities and plans, management, and monitoring of operational compliance related tasks. These tasks are to include internal auditing and monitoring activities, external audit coordination, and regulatory training and education.
Responsibilities:
- Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of Leaders.
- Review and research laws and regulations both on a reactive and proactive basis to ensure an effective and accurate response to legal and regulatory compliance for Medicare Advantage and Health Exchange lines of business.
- Monitors Health Plan progress in resolution of issues identified through the Risk Assessment and Monitoring Work Plan and internal and external audit findings.
- Analyze and periodically report on risk-related trends to the Compliance Committee to ensure organizational awareness of potential noncompliance.
- Perform ongoing internal monitoring/audits based on risk level.
- Support implementation of consistent processes to enhance compliance within day-to-day health plan operations.
- Provide specialized education and development of materials as requested.
- Follow up with Action items necessary related to various audit requests and compliance related issues.
- Work with the regulatory affairs team to develop streamlined approaches between lines of business.
- Cross-train the regulatory affairs team on compliance related tasks to ensure operational compliance goals are met.
- Excellent interpersonal skills with regular interaction and communication with the Senior Leadership team and other associates within the organization.
- Ability to facilitate the resolution of issues and concerns that create barriers to a high-performing team and work environment.
- Ability to manage project/monitoring work plans for achieving project goals and objectives.
- Coordinates assigned projects, including monitoring projects to present to leadership and regulatory bodies.
- Serves as Project Manager on external compliance audits conducted by regulatory bodies.
- Serves as a resource in regulatory guidance for Health Exchange and Medicare Lines of Business.
- Performs other duties as assigned.
Job Requirements:
Education/Skills
- Bachelor's Degree in Related Field of Study and or equivalent years of work experience required
Experience
- 4 - 6 years of related experience preferred
Licenses, Registrations, or Certifications
- None required
In accordance with the CHRISTUS Health License, Certification and Registration Verification Policy, all Associates are required to obtain the required certifications for their respective positions within the designated time frame.
Work Schedule:
8AM - 5PM Monday-Friday
Work Type:
Full Time
See all 72+ OPT Regulatory Affairs Manager Jobs
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Get Access To All JobsTips for Finding OPT Sponsorship as a Regulatory Affairs Manager
Target STEM-designated programs first
Regulatory Affairs Manager roles frequently fall under STEM OPT extension eligibility. Confirm your degree program's CIP code qualifies before applying, as this gives you up to 24 additional months of work authorization to secure H-1B visa sponsorship.
Focus on regulated industries with established immigration programs
Pharma, biotech, and medical device companies sponsor OPT workers far more consistently than other sectors. These industries have compliance-driven hiring structures and legal teams already familiar with work authorization timelines, making sponsorship conversations less friction-heavy.
Lead with your regulatory credentials in applications
RAC certification, FDA submission experience, or hands-on work with 510(k) or IND filings signals specialized expertise. Employers weigh sponsorship costs against candidate value, so concrete credentials make the business case for sponsoring your visa status stronger.
Time your applications around your OPT expiration window
Apply at least six months before OPT expires so employers have runway to file an H-1B petition or explore cap-exempt options. Hiring managers need time for internal approvals, and compressing that timeline often kills otherwise viable sponsorship conversations.
Understand the specialty occupation argument for your role
Regulatory Affairs Manager qualifies as a specialty occupation because it requires a specific life sciences or engineering degree. Being able to articulate that clearly to a hiring manager removes a common objection and shows you understand the visa process.
Ask about sponsorship policy during the first interview
Raise work authorization early rather than after an offer. Ask specifically whether the company has sponsored H-1B petitions for this role before. A prior sponsorship history in regulatory affairs is the strongest signal that sponsorship is genuinely available.
Regulatory Affairs Manager OPT: Frequently Asked Questions
Does a Regulatory Affairs Manager role qualify for the STEM OPT extension?
It depends on your underlying degree. If your degree is in a STEM-designated field such as biochemistry, biomedical engineering, chemistry, or pharmaceutical sciences, you likely qualify for the 24-month STEM OPT extension. The extension is tied to your degree's CIP code, not your job title. Confirm your program qualifies through your DSO before accepting an offer that depends on the extended timeline.
What types of employers hire Regulatory Affairs Managers on OPT?
Pharmaceutical companies, biotechs, medical device manufacturers, and contract research organizations are the most active sponsors for this role. These employers operate in heavily regulated environments where regulatory affairs expertise is a core business function, not a peripheral one, making them more willing to invest in sponsorship. Browse Migrate Mate to filter specifically for employers that have sponsored OPT workers in this field.
Can I work as a Regulatory Affairs Manager on standard 12-month OPT without a STEM extension?
Yes. Standard OPT authorizes full-time employment in a role related to your degree field, and Regulatory Affairs Manager qualifies if your degree is in life sciences, chemistry, engineering, or a closely related discipline. The practical challenge is that 12 months is a short window for an employer to initiate H-1B sponsorship, so companies with experience sponsoring OPT workers are a better fit than those new to the process.
Does the Regulatory Affairs Manager role qualify as a specialty occupation for H-1B purposes?
Generally yes. The role requires specialized knowledge of regulatory frameworks such as FDA regulations, EU MDR, or ICH guidelines, and a specific bachelor's degree or higher in a related field is the standard entry requirement. USCIS has approved H-1B petitions for regulatory affairs roles consistently, though individual petition outcomes depend on how the employer defines the position in the Labor Condition Application.
What should I do if an employer says they don't sponsor visas for this role?
First, clarify whether they mean H-1B specifically or all work authorization. Some employers are unfamiliar with OPT, which doesn't require them to file a petition and has minimal administrative burden. If they still decline, prioritize employers with a documented sponsorship history. Focusing your search on verified sponsoring employers from the start saves significant time.