Regulatory Affairs Specialist Jobs in USA with Visa Sponsorship
Regulatory Affairs Specialists are in strong demand from H-1B and E-3 sponsoring employers across pharma, biotech, and medical device companies. Most roles require a science or engineering degree, qualify as specialty occupations, and come with multi-year visa sponsorship. For detailed occupation requirements, see the O*NET profile.
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Get Access To All JobsWe anticipate the application window for this opening will close on - 24 Mar 2026
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
The Cardiac Rhythm Management operating group is a division within Medtronic focused on developing and manufacturing medical devices and solutions for the management of cardiac arrhythmias and heart failure. This group’s product portfolio includes implantable pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices, and remote monitoring systems. CRM’s mission is to improve patient outcomes and quality of life by providing innovative therapies for the detection, prevention, and treatment of abnormal heart rhythms. The group collaborates closely with healthcare professionals and leverages advanced technology and data-driven insights to drive improvements in cardiac care.
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
This position will be based in Mounds View, MN. The Associate Regulatory Affairs Specialist is responsible for collaborating, planning and executing regulatory activities related to Class II and Class III Cardiac devices and therapies to markets for the US FDA and EU Notified Bodies. You will be assessing the regulatory impact of post-market changes to cleared & approved products and processes and coordinate the implementation of any resulting regulatory strategy for the worldwide market. You will also be coordinating with our regulatory partners worldwide for new device registrations, renewals, and tenders for OUS markets.
Role and Responsibilities
Responsibilities may include the following and other duties may be assigned.
- Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
- Leads or compiles all materials required in submissions, license renewal and annual registrations.
- Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
- Monitors and improves tracking / control systems.
- Keeps abreast of regulatory procedures and changes.
- May direct interaction with regulatory agencies on defined matters.
- Recommends strategies for earliest possible approvals of clinical trials applications.
Must Have, Minimum Requirements
- Bachelor's Degree
- 0 regulatory affairs experience
Nice To Have
- Bachelor’s Degree in a health profession, science and/or engineering field
- Experience in medical device industry
- Demonstrated technical writing skills
- Strong computer skills, including word processing, spreadsheets and slide presentations
- Excellent organizational, project management skills
- Strong written, verbal and interpersonal skills
- Notary license
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
U.S. Work Authorization & Sponsorship
At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Salary ranges for U.S (excl. PR) locations (USD): $60,000.00 - $90,000.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We anticipate the application window for this opening will close on - 24 Mar 2026
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
The Cardiac Rhythm Management operating group is a division within Medtronic focused on developing and manufacturing medical devices and solutions for the management of cardiac arrhythmias and heart failure. This group’s product portfolio includes implantable pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices, and remote monitoring systems. CRM’s mission is to improve patient outcomes and quality of life by providing innovative therapies for the detection, prevention, and treatment of abnormal heart rhythms. The group collaborates closely with healthcare professionals and leverages advanced technology and data-driven insights to drive improvements in cardiac care.
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
This position will be based in Mounds View, MN. The Associate Regulatory Affairs Specialist is responsible for collaborating, planning and executing regulatory activities related to Class II and Class III Cardiac devices and therapies to markets for the US FDA and EU Notified Bodies. You will be assessing the regulatory impact of post-market changes to cleared & approved products and processes and coordinate the implementation of any resulting regulatory strategy for the worldwide market. You will also be coordinating with our regulatory partners worldwide for new device registrations, renewals, and tenders for OUS markets.
Role and Responsibilities
Responsibilities may include the following and other duties may be assigned.
- Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
- Leads or compiles all materials required in submissions, license renewal and annual registrations.
- Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
- Monitors and improves tracking / control systems.
- Keeps abreast of regulatory procedures and changes.
- May direct interaction with regulatory agencies on defined matters.
- Recommends strategies for earliest possible approvals of clinical trials applications.
Must Have, Minimum Requirements
- Bachelor's Degree
- 0 regulatory affairs experience
Nice To Have
- Bachelor’s Degree in a health profession, science and/or engineering field
- Experience in medical device industry
- Demonstrated technical writing skills
- Strong computer skills, including word processing, spreadsheets and slide presentations
- Excellent organizational, project management skills
- Strong written, verbal and interpersonal skills
- Notary license
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
U.S. Work Authorization & Sponsorship
At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Salary ranges for U.S (excl. PR) locations (USD): $60,000.00 - $90,000.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
How to Get Visa Sponsorship as a Regulatory Affairs Specialist
Target industries with established sponsorship track records
Pharmaceutical, biotechnology, and medical device companies sponsor Regulatory Affairs Specialists at high rates. These industries have dedicated HR and legal teams experienced with H-1B and E-3 filings, making the process smoother than in smaller or less regulated sectors.
Confirm your degree aligns with the specialty occupation standard
USCIS requires a direct relationship between your degree field and the role. A degree in chemistry, biology, pharmaceutical sciences, or biomedical engineering typically satisfies this. A general business degree alone usually does not, even with years of regulatory experience.
Understand that government affairs roles can complicate cap-exempt petitions
Some Regulatory Affairs roles at universities or nonprofit research institutions may qualify for cap-exempt H-1B status. If your target employer has an academic or nonprofit affiliate, ask whether cap-exempt filing is available before assuming lottery entry is required.
Get your foreign credentials evaluated early
If you completed your degree outside the U.S., a credential evaluation from a NACES-approved organization confirms U.S. equivalency. Employers and immigration attorneys need this before filing. Starting early avoids delays once a job offer is extended.
Highlight regulatory submissions and agency experience in your application
FDA, EMA, or TGA submission experience signals direct value to sponsoring employers. Companies weighing sponsorship costs want clear justification. Concrete examples of IND, NDA, or 510(k) submissions make the hiring case stronger and the sponsorship decision easier.
Ask about visa type flexibility when negotiating your offer
Australians should ask whether the employer will support an E-3 instead of H-1B. The E-3 has no lottery, processes faster, and costs less. Many employers are unaware of it, but most find it straightforward once their immigration attorney reviews the requirements.
Regulatory Affairs Specialist jobs are hiring across the US. Find yours.
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Get Access To All JobsFrequently Asked Questions
Do Regulatory Affairs Specialist roles qualify for H-1B sponsorship?
Yes. Regulatory Affairs Specialist is a recognized specialty occupation under H-1B standards because the role typically requires a bachelor's degree or higher in a specific scientific or technical field. USCIS has approved H-1B petitions for this title across pharmaceutical, biotech, and medical device companies. Roles that require only general education or where any degree field satisfies the requirement are harder to qualify, so the job description wording matters.
What degree do I need to get visa sponsorship as a Regulatory Affairs Specialist?
Most sponsoring employers require a bachelor's degree in life sciences, chemistry, biomedical engineering, pharmacy, or a related field. Some senior roles accept a combination of a lower-level degree plus relevant work experience under the 3-for-1 rule, where three years of qualifying experience substitutes for one year of education. A degree in an unrelated field makes it significantly harder for the employer to satisfy USCIS's specialty occupation requirement.
Are Australian citizens eligible for the E-3 visa for Regulatory Affairs roles?
Yes. Australian citizens with a qualifying science or engineering degree can work in the U.S. as a Regulatory Affairs Specialist on an E-3 visa. The E-3 has no lottery, is available year-round, and renews in two-year increments with no cap on renewals. Employers need to file a Labor Condition Application with the Department of Labor before you apply, but the overall process is significantly faster than the H-1B.
How competitive is visa sponsorship for Regulatory Affairs Specialists compared to other roles?
More straightforward than many technical roles. Pharmaceutical and medical device companies are experienced sponsors with in-house immigration support, and the specialty occupation case for this title is well-established. The main risk is lottery dependency for H-1B roles, which affects all cap-subject applicants equally. Australians using the E-3 avoid the lottery entirely. Browse current sponsored openings on Migrate Mate to see which employers are actively hiring and sponsoring.
Can I switch employers on an H-1B while working as a Regulatory Affairs Specialist?
Yes, through H-1B portability. If you've been in valid H-1B status for at least 180 days after approval and your new employer files a transfer petition before your current status expires, you can start the new role as soon as the petition is received by USCIS. You don't need to wait for approval. The new employer must file a fresh Labor Condition Application, and the role must still qualify as a specialty occupation.
What is the prevailing wage requirement for sponsored Regulatory Affairs Specialist 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.
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