E-3 Visa Regulatory Affairs Manager Jobs
Regulatory Affairs Manager roles qualify as E-3 specialty occupations, making them a strong fit for Australian professionals seeking U.S. sponsorship. The E-3 has no lottery and renews in two-year increments, so your career isn't tied to a single registration window the way H-1B holders' careers are.
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Get Access To All JobsCOMPANY DESCRIPTION
Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs.
Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence.
JOB DESCRIPTION
Required: (Remote Opportunity - Temp to Perm)
- The Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations.
- In this role, you will lead the preparation, analysis, and submissions dossiers to various governing agencies in supporting business growth.
- The RA Manager supports compliance with applicable regulations including ISO, local, state, and/or federal requirements.
- Preparing international regulatory submissions and FDA submissions which may include device 510(k), IDEs, PMAs) and serving as regulatory representative on selected project teams; developing departmental SOPs/policies regarding regulatory matters.
Key responsibilities:
- Lead Regulatory Associates or Specialists in addition to work as an individual contributor
- Prepare, review and file FDA premarket submission to ensure devices are commercially available in the U.S.: pre-IDEs, IDEs, 510(k)s, PMAs and PMA Supplements. (Will also be involved in EU submissions)
- Represent RA as core team member to drive innovation on Tech. Dev. Projects and follow through to market release.
- Develop Regulatory Strategies for new or modified products and prepare project plans & budgets.
- Monitor and provide management with impact of changes in the Regulatory environment.
- Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions under the direction of management.
- Document, consolidate and maintain oral and written communication with FDA, notified bodies, and clinical investigators.
- Support Design Control process.
- Prepare Rational to file documentation for modifications to devices when appropriate.
- Participate in FDA & other notified body Inspections.
- Author and/or review regulatory procedures and update as necessary.
- Review change control documents and ascertain Regulatory impact for external and internal documents.
- Assist in development/maintenance of regulatory files, records and reporting systems of systematic retrieval of information.
- Review promotional material and labeling for regulatory compliance.
QUALIFICATIONS
Required qualifications: (Remote Opportunity)
- Bachelor's degree required. Scientific or engineering field preferred.
- 5+ years of medical device regulatory affairs experience.
- Must have authored 510(k) submissions
- Must have knowledge of U.S. FDA regulations and standards
- 3+ years of experience interacting with FDA and/or other regulatory agencies
- Experience with devices containing software is strongly preferred.
- Must work well in team environments
- Must demonstrate leadership skills in team setting.
- Proven analytical abilities
- Solid understanding of manufacturing and change control, and an awareness of regulatory trends
ADDITIONAL INFORMATION
To know more on this position or to schedule an interview, please contact;
Ujjwal Mane
973-805-7557
ujjwal.mane[@]collabera.com
COMPANY DESCRIPTION
Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs.
Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence.
JOB DESCRIPTION
Required: (Remote Opportunity - Temp to Perm)
- The Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations.
- In this role, you will lead the preparation, analysis, and submissions dossiers to various governing agencies in supporting business growth.
- The RA Manager supports compliance with applicable regulations including ISO, local, state, and/or federal requirements.
- Preparing international regulatory submissions and FDA submissions which may include device 510(k), IDEs, PMAs) and serving as regulatory representative on selected project teams; developing departmental SOPs/policies regarding regulatory matters.
Key responsibilities:
- Lead Regulatory Associates or Specialists in addition to work as an individual contributor
- Prepare, review and file FDA premarket submission to ensure devices are commercially available in the U.S.: pre-IDEs, IDEs, 510(k)s, PMAs and PMA Supplements. (Will also be involved in EU submissions)
- Represent RA as core team member to drive innovation on Tech. Dev. Projects and follow through to market release.
- Develop Regulatory Strategies for new or modified products and prepare project plans & budgets.
- Monitor and provide management with impact of changes in the Regulatory environment.
- Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions under the direction of management.
- Document, consolidate and maintain oral and written communication with FDA, notified bodies, and clinical investigators.
- Support Design Control process.
- Prepare Rational to file documentation for modifications to devices when appropriate.
- Participate in FDA & other notified body Inspections.
- Author and/or review regulatory procedures and update as necessary.
- Review change control documents and ascertain Regulatory impact for external and internal documents.
- Assist in development/maintenance of regulatory files, records and reporting systems of systematic retrieval of information.
- Review promotional material and labeling for regulatory compliance.
QUALIFICATIONS
Required qualifications: (Remote Opportunity)
- Bachelor's degree required. Scientific or engineering field preferred.
- 5+ years of medical device regulatory affairs experience.
- Must have authored 510(k) submissions
- Must have knowledge of U.S. FDA regulations and standards
- 3+ years of experience interacting with FDA and/or other regulatory agencies
- Experience with devices containing software is strongly preferred.
- Must work well in team environments
- Must demonstrate leadership skills in team setting.
- Proven analytical abilities
- Solid understanding of manufacturing and change control, and an awareness of regulatory trends
ADDITIONAL INFORMATION
To know more on this position or to schedule an interview, please contact;
Ujjwal Mane
973-805-7557
ujjwal.mane[@]collabera.com
See all 5+ Regulatory Affairs Manager jobs
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Get Access To All JobsTips for Finding E-3 Visa Sponsorship as a Regulatory Affairs Manager
Translate your TGA credentials for U.S. employers
Experience with the Therapeutic Goods Administration maps directly to FDA regulatory frameworks, but U.S. hiring managers may not make that connection automatically. Frame your TGA submissions and compliance work in terms of 21 CFR Part 11 and IND or NDA filing processes.
Target employers with active FDA dockets
Search the FDA's public drug or device approval databases to identify companies with recent 510(k), PMA, or NDA activity. These employers have active regulatory pipelines and a demonstrated need for the specialised oversight that a Regulatory Affairs Manager provides.
Clarify E-3 eligibility before the offer stage
Regulatory Affairs Manager roles routinely satisfy the E-3 specialty occupation requirement because the position normally demands a bachelor's degree in a relevant science, engineering, or regulatory discipline. Confirm this with your prospective employer before formal negotiations begin.
Request LCA filing the week your offer is signed
The DOL must certify your Labor Condition Application before you can apply for your E-3 visa. Delays here push back your consulate appointment, so ask your employer to submit the LCA through DOL's FLAG system immediately after your offer letter is executed.
Use Migrate Mate's E-3 filing service for the full process
Regulatory Affairs roles often involve complex job descriptions that need precise framing in the LCA and visa application. Migrate Mate's E-3 filing service manages your LCA submission, visa paperwork, and consulate preparation end-to-end so nothing stalls your start date.
Prepare for specialty occupation questions at the consulate
Consular officers occasionally probe whether a Regulatory Affairs Manager role genuinely requires a degree rather than general business experience. Bring your offer letter, an organisational chart showing the technical scope of the role, and copies of any relevant regulatory certifications.
Regulatory Affairs Manager jobs are hiring across the US. Find yours.
Find Regulatory Affairs Manager JobsRegulatory Affairs Manager E-3 Visa: Frequently Asked Questions
How do I find Regulatory Affairs Manager jobs that offer E-3 visa sponsorship?
Migrate Mate lets you filter job listings specifically by E-3 visa sponsorship, so you're not sorting through roles that won't support the visa. Regulatory Affairs Manager positions are listed by industry sector, which helps you target pharmaceutical, medical device, or biotech employers whose compliance needs align with your background.
How much does it cost to get an E-3 visa?
Migrate Mate's E-3 filing service covers the entire process for $499, including the Labor Condition Application, visa document preparation, and consulate appointment guidance. Traditional immigration lawyers charge $2,000–$5,000+ for the same work. The E-3 has less paperwork than most work visas, so paying thousands for legal help is usually unnecessary.
Does a Regulatory Affairs Manager role qualify as an E-3 specialty occupation?
Yes. The E-3 specialty occupation requirement is satisfied when the position normally requires a bachelor's degree or higher in a specific field. Regulatory Affairs Manager roles typically demand a degree in life sciences, pharmacy, engineering, or a related discipline, along with specialist knowledge of FDA or international regulatory frameworks, which meets that standard.
How does the E-3 visa compare to the H-1B for Regulatory Affairs Managers?
The E-3 has a 10,500 annual allocation that has never been exhausted, so there's no lottery. H-1B registrations are capped at 85,000 and subject to a randomised selection process that rejected roughly two-thirds of registrations in recent fiscal years. For an Australian Regulatory Affairs Manager, the E-3 provides a direct, predictable path without the lottery risk that makes H-1B sponsorship unreliable.
Can I switch employers or move to a contract role on an E-3 as a Regulatory Affairs Manager?
You can change employers, but each new position requires a fresh LCA certified by the DOL and a new E-3 visa application before you start work. Contract or consulting arrangements are more complicated because the E-3 requires an employer-employee relationship with a U.S. entity; purely independent contractor structures generally don't qualify.
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