H-1B1 Singapore Visa Regulatory Affairs Jobs
Regulatory Affairs jobs in the U.S. require a bachelor's degree in a life sciences or related field, qualifying them as H-1B1 specialty occupations. Singaporean professionals can pursue H-1B1 Singapore visa sponsorship without entering a lottery, with 5,400 annual slots that consistently go unfilled and consulate processing that skips the USCIS petition stage entirely.
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Get Access To All JobsINTRODUCTION
Highly experienced Principal Regulatory Affairs Specialist to lead and support global post-market regulatory compliance activities within the Interventional Cardiology and Vascular Therapies Division. This role is responsible for ensuring compliance with global regulatory requirements related to product incident reporting, corrective and preventive actions (CAPA), recalls, field actions, audits, and post-market surveillance activities. The ideal candidate will possess deep knowledge of U.S. and international medical device regulations, strong analytical capabilities, and the ability to collaborate effectively across cross-functional teams to drive compliance and continuous improvement initiatives.
ROLE AND RESPONSIBILITIES:
- Lead regulatory activities supporting product corrections, recalls, and field actions.
- Partner with internal global regulatory teams and external regulatory authorities regarding recall-related communications and submissions.
- Manage Product Incident Reports (PIRs), including investigation, risk assessment, documentation, and regulatory reporting.
- Drive development, implementation, and monitoring of CAPAs to address nonconformances and improve regulatory processes.
- Support internal and external audits, inspections, and compliance assessments.
- Ensure compliance with FDA regulations, EU MDR requirements, and other international regulatory frameworks.
- Monitor evolving global regulatory requirements and communicate regulatory updates to stakeholders.
- Provide regulatory guidance for post-market surveillance and quality-related activities.
- Develop and deliver regulatory compliance training to internal teams.
- Collaborate with Quality, Clinical, Engineering, Manufacturing, and Commercial teams to ensure regulatory compliance throughout the product lifecycle.
BASIC QUALIFICATIONS:
- Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or a related scientific/technical discipline, along with 12+ years of relevant industry experience.
- Minimum 5 years of experience in Regulatory Affairs and/or Quality within the medical device, healthcare, or life sciences industry.
- Minimum 2 years of direct Regulatory Affairs experience.
- Strong knowledge of U.S. FDA regulations and medical device regulatory requirements.
Experience managing:
- Product Incident Reports (PIRs)
- Corrective and Preventive Actions (CAPAs)
- Product recalls and field corrective actions
- Audit and inspection support activities
- Experience using regulatory systems, databases, and documentation tools.
- Strong written and verbal communication skills.
COMPENSATION
- The pay range that the employer in good faith reasonably expects to pay for this position is $39.30/hour - $61.40/hour. Our benefits include medical, dental, vision and retirement benefits. Applications will be accepted on an ongoing basis.
LOCATION
Maple Grove, MN, United States (On-site)
Contract (1 year 5 days)
Tundra Technical Solutions is among North America’s leading providers of Staffing and Consulting Services. Our success and our clients’ success are built on a foundation of service excellence. We are an equal opportunity employer, and we do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability, genetic information, or other applicable legally protected characteristic. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Unincorporated LA County workers: we reasonably believe that criminal history may have a direct, adverse and negative relationship with the following job duties, potentially resulting in the withdrawal of a conditional offer of employment: client provided property, including hardware (both of which may include data) entrusted to you from theft, loss or damage; return all portable client computer hardware in your possession (including the data contained therein) upon completion of the assignment, and; maintain the confidentiality of client proprietary, confidential, or non-public information. In addition, job duties require access to secure and protected client information technology systems and related data security obligations.
INTRODUCTION
Highly experienced Principal Regulatory Affairs Specialist to lead and support global post-market regulatory compliance activities within the Interventional Cardiology and Vascular Therapies Division. This role is responsible for ensuring compliance with global regulatory requirements related to product incident reporting, corrective and preventive actions (CAPA), recalls, field actions, audits, and post-market surveillance activities. The ideal candidate will possess deep knowledge of U.S. and international medical device regulations, strong analytical capabilities, and the ability to collaborate effectively across cross-functional teams to drive compliance and continuous improvement initiatives.
ROLE AND RESPONSIBILITIES:
- Lead regulatory activities supporting product corrections, recalls, and field actions.
- Partner with internal global regulatory teams and external regulatory authorities regarding recall-related communications and submissions.
- Manage Product Incident Reports (PIRs), including investigation, risk assessment, documentation, and regulatory reporting.
- Drive development, implementation, and monitoring of CAPAs to address nonconformances and improve regulatory processes.
- Support internal and external audits, inspections, and compliance assessments.
- Ensure compliance with FDA regulations, EU MDR requirements, and other international regulatory frameworks.
- Monitor evolving global regulatory requirements and communicate regulatory updates to stakeholders.
- Provide regulatory guidance for post-market surveillance and quality-related activities.
- Develop and deliver regulatory compliance training to internal teams.
- Collaborate with Quality, Clinical, Engineering, Manufacturing, and Commercial teams to ensure regulatory compliance throughout the product lifecycle.
BASIC QUALIFICATIONS:
- Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or a related scientific/technical discipline, along with 12+ years of relevant industry experience.
- Minimum 5 years of experience in Regulatory Affairs and/or Quality within the medical device, healthcare, or life sciences industry.
- Minimum 2 years of direct Regulatory Affairs experience.
- Strong knowledge of U.S. FDA regulations and medical device regulatory requirements.
Experience managing:
- Product Incident Reports (PIRs)
- Corrective and Preventive Actions (CAPAs)
- Product recalls and field corrective actions
- Audit and inspection support activities
- Experience using regulatory systems, databases, and documentation tools.
- Strong written and verbal communication skills.
COMPENSATION
- The pay range that the employer in good faith reasonably expects to pay for this position is $39.30/hour - $61.40/hour. Our benefits include medical, dental, vision and retirement benefits. Applications will be accepted on an ongoing basis.
LOCATION
Maple Grove, MN, United States (On-site)
Contract (1 year 5 days)
Tundra Technical Solutions is among North America’s leading providers of Staffing and Consulting Services. Our success and our clients’ success are built on a foundation of service excellence. We are an equal opportunity employer, and we do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability, genetic information, or other applicable legally protected characteristic. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Unincorporated LA County workers: we reasonably believe that criminal history may have a direct, adverse and negative relationship with the following job duties, potentially resulting in the withdrawal of a conditional offer of employment: client provided property, including hardware (both of which may include data) entrusted to you from theft, loss or damage; return all portable client computer hardware in your possession (including the data contained therein) upon completion of the assignment, and; maintain the confidentiality of client proprietary, confidential, or non-public information. In addition, job duties require access to secure and protected client information technology systems and related data security obligations.
See all H-1B1 Singapore Visa Regulatory Affairs Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B1 Singapore Visa Regulatory Affairs Jobs.
Get Access To All JobsTips for Finding Regulatory Affairs Jobs
Align your credentials to U.S. regulatory standards
Singaporean degrees in pharmacy, chemistry, biomedical science, or engineering are recognized for H-1B1 visa specialty occupation purposes, but your transcript must show a direct field relationship to the Regulatory Affairs role. Have an official translation and credential evaluation ready before you apply.
Target employers with active FDA submission pipelines
Pharmaceutical, medical device, and biotech companies filing NDAs, 510(k)s, or BLAs with the FDA need in-house Regulatory Affairs staff year-round. These employers are far more likely to understand H-1B1 Singapore visa sponsorship than general industry firms without U.S. market ambitions.
Search verified H-1B1 Singapore job listings on Migrate Mate
Migrate Mate filters Regulatory Affairs roles by employers with documented H-1B1 visa and H-1B visa LCA filing history, so you're not cold-applying to companies that have never sponsored a Singaporean professional before.
Confirm your job description satisfies specialty occupation language
Your offer letter and job description must state that a bachelor's degree in a specific field is required, not merely preferred. Vague language like 'degree or equivalent experience' can create problems at the consulate even when your credentials are strong.
Verify the prevailing wage tier before accepting an offer
Your employer's LCA must certify a wage at or above the DOL prevailing wage for your occupation code and work location. Use the OFLC Wage Search to check the applicable wage level for Regulatory Affairs roles in your target city before negotiating.
Prepare for consulate-only processing and no USCIS filing wait
Unlike H-1B, your employer doesn't file an I-129 petition with USCIS. The LCA goes to DOL, then you apply directly at the U.S. Embassy in Singapore. Coordinate your interview scheduling with your employer's LCA certification timeline to avoid gaps.
Frequently Asked Questions
Does a Regulatory Affairs role qualify as a specialty occupation under the H-1B1 Singapore visa?
Yes. Regulatory Affairs positions typically require a bachelor's degree or higher in pharmacy, chemistry, biomedical science, life sciences, or a closely related field, which satisfies the H-1B1 visa specialty occupation definition. Your job description must explicitly state that the degree is required, not just preferred, and the field must have a direct relationship to the duties of the role.
How does the H-1B1 Singapore visa differ from H-1B for Regulatory Affairs professionals?
The H-1B1 Singapore visa has no lottery and no USCIS petition filing, so your employer submits an LCA to DOL and you apply directly at the U.S. Embassy in Singapore. The H-1B requires a USCIS petition and subjects you to an annual lottery with roughly a 25% selection rate. For Singaporean nationals, the H-1B1 is a direct path that bypasses the lottery entirely, with 5,400 annual slots that have never been exhausted.
How do I find Regulatory Affairs employers who actually sponsor H-1B1 Singapore visas?
Migrate Mate shows Regulatory Affairs roles filtered by employers with verified LCA filing history for H-1B1 visa and H-1B petitions, so you can identify companies that have sponsored roles in your occupation before. Targeting employers with active FDA submission pipelines in pharma, biotech, and medical devices gives you the strongest pool of willing sponsors.
Can my employer file an H-1B1 while I'm already in the U.S. on another visa status?
H-1B1 Singapore visas are generally processed through consular processing at the U.S. Embassy in Singapore, not through a change of status filed with USCIS. If you're currently in the U.S. on F-1 OPT or another status, you would typically need to apply for the H-1B1 visa stamp at a consulate before or after your authorized stay, rather than adjusting status domestically.
What documents should I prepare before a Regulatory Affairs employer agrees to sponsor my H-1B1?
Have your academic transcripts, degree certificates, and a credential evaluation confirming field equivalency ready before the offer stage. Your employer will need these to support the specialty occupation determination in the LCA. You should also have your O*NET occupation profile for Regulatory Affairs roles printed to demonstrate the standard degree requirement for the position to any employer unfamiliar with the process.