H-1B Visa Regulatory Specialist Jobs
Regulatory Specialist roles qualify as H-1B visa specialty occupations when tied to a bachelor's degree in regulatory affairs, life sciences, chemistry, or a related technical field. Employers sponsor H-1B petitions for specialists in FDA compliance, environmental regulation, and pharmaceutical quality, with status granted for up to three years and extendable to six.
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INTRODUCTION
We are the people who give possibilities purpose
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
JOB DESCRIPTION
The Regulatory Affairs Strategist, Globalization is responsible implementation worldwide regulatory affairs strategies and practices related to their assigned area of focus and expertise across BU, Regional and Central teams. Act as a strategic partner to Business Units and Regional Regulatory leaders, enabling aligned execution of assigned business practices through tools, processes, and best‑practice sharing. The role requires an understanding of the Regulatory function related to their area of focus and its associated activities.
Responsibilities:
- Provide centralized regulatory governance related to the regulatory change management, release, and restriction process. Able to interpret global regulatory requirements, ensuring timely insight and clear guidance to Business Units and Regions to enable compliant growth and market access.
- Help to develop and standardize regulatory releases and restrictions, driving consistency, efficiency, and scalability across regions while allowing appropriate flexibility to meet local regulatory needs.
- Act as a partner to Business Units and Regional Regulatory leaders, enabling implementation of global processes related to releases and restrictions.
- Coordinates and networks across Business Units, Regions, Central RA related to releases and restrictions, and helps to identify areas for improvement.
- Works across regulatory affairs teams to identify common pain points and potential solutions.
- Stays apprised of global regulatory policy topics.
MINIMUM QUALIFICATIONS
- Bachelor’s degree in science, engineering, or technology discipline required.
- Minimum of 3 years of experience in Regulatory Affairs, Quality, Compliance, Product Stewardship, or a related regulated function.
- Experience supporting regulatory compliance activities in a regulated industry (medical device, pharmaceutical, biotechnology, diagnostics, healthcare, consumer products, or similar).
- Experience interpreting and applying regulatory requirements and communicating impacts to stakeholders.
- Demonstrated experience coordinating cross-functional projects involving multiple stakeholders.
- Strong written and verbal communication skills with the ability to translate complex regulatory information into clear business guidance.
- Ability to manage multiple priorities and work effectively in a global, matrixed environment.
PREFERRED QUALIFICATIONS
- Master’s degree in business, management, or technology related field preferred.
- Experienced in both Business and Regional roles.
- Regulatory Affairs Certification (RAC).
- Experience with regulatory change management, product releases, restrictions, market access, or lifecycle management processes.
- Experience supporting globalization initiatives, regulatory harmonization efforts, or process standardization projects.
- Demonstrated ability to influence stakeholders and drive alignment across Business Units, Regions, and Corporate functions without direct authority.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
At BD, we are committed to supporting our associates’ well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role:
- Annual Bonus
- Potential Discretionary LTI Bonus
Health and Well-being Benefits
- Medical coverage
- Health Savings Accounts
- Flexible Spending Accounts
- Dental coverage
- Vision coverage
- Hospital Care Insurance
- Critical Illness Insurance
- Accidental Injury Insurance
- Life and AD&D insurance
- Short-term disability coverage
- Long-term disability insurance
- Long-term care with life insurance
Other Well-being Resources
- Anxiety management program
- Wellness incentives
- Sleep improvement program
- Diabetes management program
- Virtual physical therapy
- Emotional/mental health support programs
- Weight management programs
- Gastrointestinal health program
- Substance use management program
- Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit
Retirement and Financial Well-being
- BD 401(k) Plan
- BD Deferred Compensation and Restoration Plan
- 529 College Savings Plan
- Financial counseling
- Baxter Credit Union (BCU)
- Daily Pay
- College financial aid and application guidance
Life Balance Programs
- Paid time off (PTO), including all required State leaves
- Educational assistance/tuition reimbursement
- MetLife Legal Plan
- Group auto and home insurance
- Pet insurance
- Commuter benefits
- Discounts on products and services
- Academic Achievement Scholarship
- Service Recognition Awards
- Employer matching donation
- Workplace accommodations
Other Life Balance Programs
- Adoption assistance
- Backup day care and eldercare
- Support for neurodivergent adults, children, and caregivers
- Caregiving assistance for elderly and special needs individuals
- Employee Assistance Program (EAP)
- Paid Parental Leave
- Support for fertility, birthing, postpartum, and age-related hormonal changes
Leave Programs
- Bereavement leaves
- Military leave
- Personal leave
- Family and Medical Leave (FML)
- Jury and Witness Duty Leave
WHY JOIN US?
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
LOCATION
Franklin Lakes, New Jersey
WORK SHIFT
At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs.
SALARY RANGE INFORMATION
$87,200.00 - $139,500.00 USD Annual
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
See all 148+ H-1B Visa Regulatory Specialist Jobs
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Regulatory Specialist
Align your degree to the regulatory discipline
USCIS evaluates whether your specific degree field directly relates to the regulatory duties you'll perform. A degree in chemistry supports FDA drug compliance roles better than a general business degree. Pull your O*NET profile to confirm which fields are listed for Regulatory Specialists before you apply.
Target employers with active LCA filing history
Search Migrate Mate to find employers who have filed certified LCAs for Regulatory Specialist positions. Employers with existing filings already understand prevailing wage obligations and the specialty occupation standard, which shortens your timeline to an offer and reduces petition risk.
Verify prevailing wage before negotiating your offer
Your employer must certify your offered wage meets or exceeds the DOL prevailing wage for your specific location and job level. Run the OFLC Wage Search using the SOC code for Regulatory Affairs Specialists before you receive a written offer so you can spot underpayment early.
Confirm each worksite gets its own certified LCA
If you'll work across multiple client sites, manufacturing facilities, or agency offices, each distinct worksite address requires a separately certified LCA. Raise this with your employer before the I-129 is filed to avoid worksite compliance gaps that could trigger a DOL audit.
Document degree equivalency for foreign credentials
If your regulatory degree came from outside the U.S., get a credential evaluation from a NACES-member evaluator before your employer files the I-129. USCIS scrutinizes foreign degree equivalency heavily for specialty occupation petitions, and a credentialing gap is a common source of Requests for Evidence.
Prepare a detailed job duties letter for the petition
Your employer's support letter must map each day-to-day regulatory duty to a specific degree-level requirement. Generic descriptions like 'ensures compliance' invite RFEs. Work with your employer before filing to build a duties narrative that connects your technical responsibilities to your academic background explicitly.
H-1B Visa Regulatory Specialist: Frequently Asked Questions
Does a Regulatory Specialist role qualify as an H-1B specialty occupation?
Yes, when the position requires at least a bachelor's degree in a directly related field such as regulatory affairs, life sciences, chemistry, pharmacy, or engineering. Roles focused on FDA submissions, environmental compliance, or pharmaceutical quality systems routinely meet the specialty occupation standard. The employer must document that the degree requirement is a genuine condition of the position, not just a preference.
Which industries sponsor H-1B visas most often for Regulatory Specialists?
Pharmaceutical and biotechnology companies, medical device manufacturers, chemical producers, and food and beverage companies with FDA-regulated product lines are the most active sponsors. Contract research organizations and regulatory consulting firms also sponsor H-1B petitions for specialists who support multiple clients. Browse verified sponsoring employers by industry on Migrate Mate to narrow your search to active filers.
How does the H-1B cap and selection process affect Regulatory Specialists?
Most Regulatory Specialist positions at for-profit companies are subject to the annual H-1B cap. The selection rules have changed recently, so check USCIS for current registration mechanics. If you hold a U.S. master's degree or higher in a qualifying field, your registration may be eligible for the advanced degree exemption pool, which runs before the general cap selection.
Can my employer transfer my H-1B to a new regulatory role or worksite?
A change to a materially different regulatory discipline, a significant shift in job duties, or a move to a new worksite location all require an amended I-129 petition and a newly certified LCA for the new location. Your employer must file the amendment before you begin working in the changed capacity. H-1B portability rules allow you to start work at a new employer once the transfer petition is filed and receipted.
What documents should I gather before my employer files my H-1B petition?
Collect your academic transcripts and diploma, a credential evaluation report if your degree is from outside the U.S., any professional certifications relevant to your regulatory discipline such as RAC or CQA, and a detailed description of your prior regulatory work experience. Your employer will also need your passport, current visa stamp, and I-94 record. Having these ready before filing reduces delays from USCIS document requests.