Green Card Senior Director Regulatory Affairs Jobs
Senior Director Regulatory Affairs roles qualify for EB-2 sponsorship when they require an advanced degree in a life sciences or regulatory discipline, and many large pharmaceutical, biotech, and medical device employers run active PERM pipelines for this title. Your path to a green card starts with finding an employer already set up to sponsor.
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Get Access To All JobsINTRODUCTION
This role is responsible for ensuring that all products comply with applicable global regulatory requirements throughout their lifecycle—from development and registration to post-market surveillance. The Regulatory Affairs Specialist helps ensure regulatory compliance for diagnostics products of ELITechGroup Inc. with FDA, Health Canada, EU, other regulatory bodies, ISO, and business objectives.
ROLE AND RESPONSIBILITIES
- Implement company regulatory affairs procedures for ELITechGroup Inc.
- Prepare, compile, and submit regulatory documentation (e.g., 510(k), PMA, CE Technical Files) to global regulatory agencies and with guidance from Regulatory Affairs Manager manage regulatory submissions.
- Interpret and apply FDA, EU MDR, ISO 13485, and other international regulations to ensure product compliance.
- Collaborate with cross-functional teams (R&D, Quality, Clinical, Marketing) to support product development and regulatory strategy.
- Review and approve product labeling, instructions for use (IFUs), and promotional materials for regulatory compliance.
- Monitor and analyze changes in regulatory requirements and communicate updates to internal stakeholders.
- Support internal and external audits, including FDA inspections and Notified Body assessments.
- Maintain regulatory files and databases, ensuring accurate and up-to-date documentation.
- Participate in post-market surveillance activities, including adverse event reporting and field actions.
- Provide regulatory input during risk assessments and design control processes.
BASIC QUALIFICATIONS
- Bachelor’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field.
- 2–5 years of experience in regulatory affairs, preferably in the medical device industry.
- Strong understanding of FDA regulations (21 CFR Part 820), EU MDR, and ISO 13485.
- Experience with regulatory submissions and product registrations in multiple global markets.
- Excellent written and verbal communication skills.
- Strong organizational and project management abilities.
PREFERRED QUALIFICATIONS
- RAC certification (Regulatory Affairs Certification).
- Experience with electronic submission systems (e.g., eSTAR, EUDAMED).
- Experience with MDSAP, ISO 14971 (risk management), and clinical evaluation reporting.
INTRODUCTION
This role is responsible for ensuring that all products comply with applicable global regulatory requirements throughout their lifecycle—from development and registration to post-market surveillance. The Regulatory Affairs Specialist helps ensure regulatory compliance for diagnostics products of ELITechGroup Inc. with FDA, Health Canada, EU, other regulatory bodies, ISO, and business objectives.
ROLE AND RESPONSIBILITIES
- Implement company regulatory affairs procedures for ELITechGroup Inc.
- Prepare, compile, and submit regulatory documentation (e.g., 510(k), PMA, CE Technical Files) to global regulatory agencies and with guidance from Regulatory Affairs Manager manage regulatory submissions.
- Interpret and apply FDA, EU MDR, ISO 13485, and other international regulations to ensure product compliance.
- Collaborate with cross-functional teams (R&D, Quality, Clinical, Marketing) to support product development and regulatory strategy.
- Review and approve product labeling, instructions for use (IFUs), and promotional materials for regulatory compliance.
- Monitor and analyze changes in regulatory requirements and communicate updates to internal stakeholders.
- Support internal and external audits, including FDA inspections and Notified Body assessments.
- Maintain regulatory files and databases, ensuring accurate and up-to-date documentation.
- Participate in post-market surveillance activities, including adverse event reporting and field actions.
- Provide regulatory input during risk assessments and design control processes.
BASIC QUALIFICATIONS
- Bachelor’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field.
- 2–5 years of experience in regulatory affairs, preferably in the medical device industry.
- Strong understanding of FDA regulations (21 CFR Part 820), EU MDR, and ISO 13485.
- Experience with regulatory submissions and product registrations in multiple global markets.
- Excellent written and verbal communication skills.
- Strong organizational and project management abilities.
PREFERRED QUALIFICATIONS
- RAC certification (Regulatory Affairs Certification).
- Experience with electronic submission systems (e.g., eSTAR, EUDAMED).
- Experience with MDSAP, ISO 14971 (risk management), and clinical evaluation reporting.
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Get Access To All JobsTips for Finding Green Card Sponsorship in Senior Director Regulatory Affairs
Verify your degree meets EB-2 requirements
An advanced degree in regulatory affairs, pharmacy, biochemistry, or a related life sciences field is the standard EB-2 baseline. A bachelor's plus five years of progressive regulatory experience can substitute if your employer documents the equivalency during PERM.
Target employers with active PERM filings
Use the OFLC Wage Search to confirm whether a prospective employer has recently filed PERM applications for regulatory affairs titles. Companies with existing PERM infrastructure move faster and understand the documentation burden for senior-level roles.
Search green card sponsoring jobs on Migrate Mate
Migrate Mate filters Senior Director Regulatory Affairs openings by green card sponsorship history, so you're applying to employers who have already navigated PERM for comparable roles rather than introducing the process to an unprepared HR team.
Align your FDA submission record with job requirements
PERM requires the employer to demonstrate no qualified U.S. worker is available. Your NDA, BLA, or 510(k) submission history, documented with dates and regulatory outcomes, strengthens the case that your credentials meet genuinely specialized requirements.
Negotiate green card sponsorship timing before accepting an offer
Ask during final-round negotiations whether the company will initiate PERM within your first year. Senior director offers with equity or sign-on bonuses are strong leverage points to formalize a sponsorship commitment before you sign.
Understand EB-2 versus EB-3 before PERM is filed
Your employer chooses the category when filing the I-140. EB-2 requires documenting an advanced degree or equivalent; EB-3 applies if the role is defined at the bachelor's level. The choice affects your priority date and wait time, so confirm it with your employer before DOL filing.
Green Card Senior Director Regulatory Affairs: Frequently Asked Questions
Does a Senior Director Regulatory Affairs role typically qualify for EB-2 or EB-3 sponsorship?
Most Senior Director Regulatory Affairs positions qualify for EB-2 because employers routinely require a master's degree or a bachelor's degree with substantial progressive experience in a regulatory discipline. If the employer defines the minimum requirement at the bachelor's level without an advanced degree requirement, EB-3 may apply instead. The PERM labor certification filing locks in the category, so confirm the degree requirement with your employer before the process begins.
How does green card sponsorship differ from H-1B for this role?
H-1B visa sponsorship is temporary, capped at 85,000 per fiscal year, and subject to a lottery for most applicants. EB-2 and EB-3 green card sponsorship through PERM is permanent residency, has no annual lottery, and results in an I-140 immigrant petition tied to your priority date rather than a temporary status. The PERM process itself takes longer to initiate, typically six months to two years from job offer to I-140 approval, but the outcome is a path to lawful permanent residency rather than a visa renewal cycle.
What does the PERM labor certification process look like for a senior regulatory role?
Your employer files the PERM application with DOL after completing a mandatory recruitment period, usually 30 to 60 days of documented U.S. candidate outreach. For a Senior Director Regulatory Affairs role, the job requirements posted during recruitment must match exactly what appears on the PERM application. DOL audits are more common for senior titles, so employers with in-house immigration counsel or prior PERM experience for regulatory roles handle this more efficiently.
How can I find Senior Director Regulatory Affairs jobs where the employer already sponsors green cards?
Migrate Mate lets you filter regulatory affairs roles specifically by green card sponsorship history, which means you're seeing employers who have already filed PERM applications for comparable titles. Applying to companies with an established sponsorship track record significantly reduces the risk that your offer falls through because the employer is unfamiliar with the PERM process or unwilling to commit to the timeline.
Can my employer start the PERM process while I'm on H-1B status?
Yes. Many foreign professionals in Senior Director Regulatory Affairs roles begin the PERM process while maintaining H-1B status. Filing PERM and an I-140 does not require you to change status, and once your I-140 is approved with a current priority date, you can file for adjustment of status to a green card through USCIS without leaving the U.S. Your H-1B can be extended beyond the standard six-year cap once your I-140 is approved and your priority date is within one year of becoming current.