Regulatory Affairs Analyst Jobs in USA with Visa Sponsorship
Regulatory Affairs Analysts are strong H-1B visa sponsorship candidates. The role qualifies as a specialty occupation requiring a relevant bachelor's degree, and employers in pharma, biotech, and medical devices routinely sponsor both H-1B and green card petitions for qualified candidates. For detailed occupation requirements, see the O*NET profile.
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Get Access To All JobsINTRODUCTION
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
- Career development with an international company where you can grow the career you dream of
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists
ABOUT THE ROLE
Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.
The Opportunity
Abbott is seeking a highly motivated and experienced Principal Regulatory Affairs Specialist to join our Vascular Division team on-site in Santa Clara, CA or Temecula, CA. In this role, you will provide regulatory leadership for a portfolio of endovascular medical devices used in the treatment of peripheral artery disease and support global regulatory strategies throughout the product lifecycle. The Principal Regulatory Affairs Specialist will manage complex regulatory activities, including on-market product support, product development projects, lifecycle management initiatives, regulatory assessments, and global submissions. This individual will serve as a key regulatory partner to cross-functional teams and contribute to strategic decision-making by interpreting regulatory requirements, evaluating business risks, and developing practical regulatory solutions. The candidate will have demonstrated experience preparing and executing regulatory strategies, supporting interactions with regulatory authorities and notified bodies, and successfully obtaining regulatory approvals for medical devices in the U.S., E.U. and other international markets.
What You’ll Work On
- Develop and execute global regulatory strategies to support product changes, manufacturing transfers, lifecycle management activities, new product development, and business objectives.
- Independently prepare regulatory submissions and documentation for medical devices.
- Lead regulatory assessments for design, manufacturing, supplier, labeling, and process changes to determine global regulatory requirements and submission strategies.
- Review and approve engineering change orders, protocols, reports, specifications, risk management documentation, validation documents, and other project-related records.
- Support and maintain U.S. and international product registrations, licenses, approvals, and technical documentation throughout the product lifecycle.
- Serve as the regulatory lead on cross-functional project teams, providing strategic guidance throughout product development and commercialization activities.
- Interpret and apply global regulatory requirements, standards, guidance documents, and industry best practices to support business needs.
- Prepare and maintain FDA submissions, including 510(k)s, PMAs, PMA supplements, and other required submissions, as applicable.
- Support EU MDR regulatory activities, including Technical Documentation updates, change assessments, and notified body interactions.
- Collaborate with Regulatory Operations, Quality, Clinical, R&D, Manufacturing, Supply Chain, Marketing, and other functional groups to ensure timely execution of regulatory deliverables.
- Analyze evolving regulatory requirements and provide recommendations regarding business impact, compliance risks, and implementation plans.
- Support regulatory authority and notified body inspections, audits, inquiries, and responses.
- Support all company initiatives in accordance with Quality Management Systems (QMS), Environmental Management Systems (EMS), and applicable regulatory requirements.
- Maintain compliance with FDA regulations, international regulations, company policies, procedures, and quality requirements.
- Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Act as liaison between the Company and the various regulatory agencies. Interfaces directly with FDA and Notified Bodies.
- May manage direct reports or serve as mentor to other regulatory affairs specialists.
- Perform other duties and responsibilities as assigned.
BASIC QUALIFICATIONS
- Bachelor’s Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)
- Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices.
- Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).
PREFERRED QUALIFICATIONS
- 6-8 years experience in medical device industry with experience working with Class II and/or Class III devices.
- Regulatory affairs professional experience supporting medical devices.
- Experience leading regulatory activities for cardiovascular, endovascular, peripheral vascular, implantable, catheter-based, or other complex medical device technologies.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
- Must be able to manage multiple and competing priorities and manage programs with minimal oversight.
- Has a strong attention-to-detail.
- Strong written, verbal, presentation, and organizational skills as well as analytical and problem-solving skills.
- Working knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.
- Experience authoring and submitting Traditional, Special, or Abbreviated 510(k)s; PMAs; PMA supplements; IDEs; or other FDA submissions.
- Experience supporting EU MDR (2017/745) Technical Documentation, change notifications, clinical evaluation documentation, or notified body interactions.
- Knowledge of global regulatory requirements and submission pathways outside the United States and European Union; in particular highly regulated countries such as China, Canada, Australia, or Brazil.
- Experience participating in regulatory authority inspections, notified body audits, and responses to regulatory inquiries.
- Experience reviewing risk-based regulatory assessments and supporting product risk management activities in accordance with ISO 14971.
- Experience reviewing clinical data.
- Experience with electronic document management systems (EDMS), product lifecycle management (PLM) systems, eQMS platforms, and change control processes.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work effectively within a team and as an individual contributor in a fast-paced, changing environment.
- Experience managing direct reports or dotted line manager to regulatory affairs specialists.
- Ability to leverage, manage and/or engage others to accomplish projects.
- Applies critical thinking to multitask, prioritize and meet deadlines in a timely manner.
- Ability to identify risk areas and escalate issues as appropriate.
COMPENSATION
- The base pay for this position is $100,000.00 – $200,000.00. In specific locations, the pay range may vary from the range posted.
The base pay for this position is $100,000.00 – $200,000.00. In specific locations, the pay range may vary from the range posted.
Abbott is an Equal Opportunity Employer, committed to employee diversity.
INTRODUCTION
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
- Career development with an international company where you can grow the career you dream of
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists
ABOUT THE ROLE
Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.
The Opportunity
Abbott is seeking a highly motivated and experienced Principal Regulatory Affairs Specialist to join our Vascular Division team on-site in Santa Clara, CA or Temecula, CA. In this role, you will provide regulatory leadership for a portfolio of endovascular medical devices used in the treatment of peripheral artery disease and support global regulatory strategies throughout the product lifecycle. The Principal Regulatory Affairs Specialist will manage complex regulatory activities, including on-market product support, product development projects, lifecycle management initiatives, regulatory assessments, and global submissions. This individual will serve as a key regulatory partner to cross-functional teams and contribute to strategic decision-making by interpreting regulatory requirements, evaluating business risks, and developing practical regulatory solutions. The candidate will have demonstrated experience preparing and executing regulatory strategies, supporting interactions with regulatory authorities and notified bodies, and successfully obtaining regulatory approvals for medical devices in the U.S., E.U. and other international markets.
What You’ll Work On
- Develop and execute global regulatory strategies to support product changes, manufacturing transfers, lifecycle management activities, new product development, and business objectives.
- Independently prepare regulatory submissions and documentation for medical devices.
- Lead regulatory assessments for design, manufacturing, supplier, labeling, and process changes to determine global regulatory requirements and submission strategies.
- Review and approve engineering change orders, protocols, reports, specifications, risk management documentation, validation documents, and other project-related records.
- Support and maintain U.S. and international product registrations, licenses, approvals, and technical documentation throughout the product lifecycle.
- Serve as the regulatory lead on cross-functional project teams, providing strategic guidance throughout product development and commercialization activities.
- Interpret and apply global regulatory requirements, standards, guidance documents, and industry best practices to support business needs.
- Prepare and maintain FDA submissions, including 510(k)s, PMAs, PMA supplements, and other required submissions, as applicable.
- Support EU MDR regulatory activities, including Technical Documentation updates, change assessments, and notified body interactions.
- Collaborate with Regulatory Operations, Quality, Clinical, R&D, Manufacturing, Supply Chain, Marketing, and other functional groups to ensure timely execution of regulatory deliverables.
- Analyze evolving regulatory requirements and provide recommendations regarding business impact, compliance risks, and implementation plans.
- Support regulatory authority and notified body inspections, audits, inquiries, and responses.
- Support all company initiatives in accordance with Quality Management Systems (QMS), Environmental Management Systems (EMS), and applicable regulatory requirements.
- Maintain compliance with FDA regulations, international regulations, company policies, procedures, and quality requirements.
- Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Act as liaison between the Company and the various regulatory agencies. Interfaces directly with FDA and Notified Bodies.
- May manage direct reports or serve as mentor to other regulatory affairs specialists.
- Perform other duties and responsibilities as assigned.
BASIC QUALIFICATIONS
- Bachelor’s Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)
- Experienced in regulatory submissions for Pharmaceutical, In vitro diagnostic devices and/or medical devices.
- Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).
PREFERRED QUALIFICATIONS
- 6-8 years experience in medical device industry with experience working with Class II and/or Class III devices.
- Regulatory affairs professional experience supporting medical devices.
- Experience leading regulatory activities for cardiovascular, endovascular, peripheral vascular, implantable, catheter-based, or other complex medical device technologies.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
- Must be able to manage multiple and competing priorities and manage programs with minimal oversight.
- Has a strong attention-to-detail.
- Strong written, verbal, presentation, and organizational skills as well as analytical and problem-solving skills.
- Working knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.
- Experience authoring and submitting Traditional, Special, or Abbreviated 510(k)s; PMAs; PMA supplements; IDEs; or other FDA submissions.
- Experience supporting EU MDR (2017/745) Technical Documentation, change notifications, clinical evaluation documentation, or notified body interactions.
- Knowledge of global regulatory requirements and submission pathways outside the United States and European Union; in particular highly regulated countries such as China, Canada, Australia, or Brazil.
- Experience participating in regulatory authority inspections, notified body audits, and responses to regulatory inquiries.
- Experience reviewing risk-based regulatory assessments and supporting product risk management activities in accordance with ISO 14971.
- Experience reviewing clinical data.
- Experience with electronic document management systems (EDMS), product lifecycle management (PLM) systems, eQMS platforms, and change control processes.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work effectively within a team and as an individual contributor in a fast-paced, changing environment.
- Experience managing direct reports or dotted line manager to regulatory affairs specialists.
- Ability to leverage, manage and/or engage others to accomplish projects.
- Applies critical thinking to multitask, prioritize and meet deadlines in a timely manner.
- Ability to identify risk areas and escalate issues as appropriate.
COMPENSATION
- The base pay for this position is $100,000.00 – $200,000.00. In specific locations, the pay range may vary from the range posted.
The base pay for this position is $100,000.00 – $200,000.00. In specific locations, the pay range may vary from the range posted.
Abbott is an Equal Opportunity Employer, committed to employee diversity.
See all 1,503+ Regulatory Affairs Analyst Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Regulatory Affairs Analyst roles.
Get Access To All JobsTips for Finding Visa Sponsorship as a Regulatory Affairs Analyst
Target regulated industries with established sponsorship pipelines
Pharmaceutical, biotechnology, and medical device companies file H-1B petitions for Regulatory Affairs Analysts at high rates. These industries have dedicated immigration budgets and HR teams experienced with the sponsorship process, making them significantly more receptive than general employers.
Match your degree field to the role's regulatory discipline
USCIS requires your degree to align with the specific regulatory domain. Life sciences, chemistry, pharmacy, biomedical engineering, or regulatory science degrees support most petitions. A business degree alone rarely satisfies the specialty occupation standard for this role without additional credentials.
Document your technical expertise in regulatory frameworks
Employers filing your H-1B petition need to demonstrate the role requires specialized knowledge. Highlight specific experience with FDA submissions, EU MDR, ICH guidelines, or 21 CFR compliance. Generic quality or compliance backgrounds are harder to support than documented regulatory specialization.
Understand that company size affects sponsorship willingness
Large pharma and medical device companies sponsor Regulatory Affairs roles routinely. Smaller biotech startups may be willing but lack internal immigration infrastructure. Confirm early whether the company has sponsored before and whether they use outside immigration counsel for H-1B filings.
Position yourself for EB-2 or EB-3 early in the H-1B process
Regulatory Affairs roles at mid-to-senior levels often support EB-2 green card petitions, especially if the work requires advanced degree knowledge. Ask employers upfront whether they support green card sponsorship alongside the H-1B, as timelines vary significantly by country of birth.
Australian citizens should evaluate the E-3 visa as an H-1B alternative
The E-3 visa covers Regulatory Affairs Analyst roles and has no lottery, no annual cap pressure, and faster processing than the H-1B. If you hold Australian citizenship and have a qualifying degree, E-3 sponsorship is often easier for employers to commit to than H-1B.
Frequently Asked Questions
Does a Regulatory Affairs Analyst role qualify for H-1B sponsorship?
Yes, Regulatory Affairs Analyst is widely recognized as a specialty occupation for H-1B purposes. USCIS expects a bachelor's degree or higher in a field directly related to the regulatory work, such as life sciences, pharmacy, biomedical engineering, or regulatory science. Petitions supported by a general business or unrelated degree face higher RFE risk, particularly at the analyst level where USCIS scrutinizes whether the degree requirement is genuinely specific to the role.
Which industries sponsor Regulatory Affairs Analysts most frequently?
Pharmaceutical, biotechnology, and medical device companies account for the large majority of H-1B sponsorships for this role, based on Department of Labor LCA disclosure data. Contract research organizations and regulatory consulting firms also sponsor regularly. Government contractors and consumer goods companies with regulated product lines occasionally sponsor, but at much lower rates. Browse current openings filtered by sponsorship willingness on Migrate Mate to identify active employers in these sectors.
What degree do I need for an employer to sponsor my H-1B as a Regulatory Affairs Analyst?
A bachelor's degree in a field directly tied to the regulatory domain is the baseline requirement. Life sciences, chemistry, biochemistry, pharmacy, biomedical engineering, and regulatory affairs-specific programs are the strongest fits. USCIS applies the specialty occupation standard strictly, so a degree in a related but tangential field should be supported by relevant coursework or postgraduate credentials. Some roles at the senior level accept an advanced degree in lieu of direct field alignment.
How strong is H-1B approval for Regulatory Affairs Analyst petitions?
Approval rates for this role are generally solid when the petition is well-documented and the degree field aligns with the regulatory specialty. The most common issue leading to Requests for Evidence is insufficient documentation that the job requires a specific degree rather than any bachelor's degree. Employers with experienced immigration counsel and a history of sponsoring this role category tend to have significantly better petition outcomes than first-time sponsors filing without legal support.
Can I get sponsored as a Regulatory Affairs Analyst on a visa other than the H-1B?
Australian citizens qualify for the E-3 visa, which covers this role and avoids the H-1B lottery entirely. Canadian and Mexican nationals may qualify under TN visa status in certain regulatory categories, though the fit depends on specific job duties and degree. O-1A visa sponsorship is possible for candidates with documented recognition in regulatory affairs, such as publications, speaking engagements, or leadership in professional organizations, though this is less common at the analyst level.
What is the prevailing wage requirement for sponsored Regulatory Affairs Analyst jobs?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.