TN Visa Regulatory Affairs Specialist Jobs
Regulatory Affairs Specialist roles qualify for TN visa sponsorship under the USMCA's Scientific Technician/Technologist or Engineer category, depending on your credentials and the role's scope. Canadian citizens can apply at the border or a U.S. consulate without a cap. Mexican citizens go through consular processing with a limited annual allocation.
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Get Access To All JobsWe anticipate the application window for this opening will close on - 11 May 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
This is an add position with a special focus on developing clinical strategies and clinical study support worldwide. This individual will also perform other regulatory duties.
PRINCIPAL REGULATORY AFFAIRS SPECIALIST – Global Clinical Trials (High-Risk Devices)
Pelvic Health
Our Pelvic Health Operating Unit advances care for patients living with bladder and bowel control conditions through targeted, minimally invasive neuromodulation therapies, including sacral and tibial solutions. Designed to modulate nerve pathways and restore communication between the brain and pelvic floor, these programmable therapies deliver personalized treatment supported by strong clinical evidence and long-term outcomes—helping improve confidence, independence, and quality of life.
Check us out on LinkedIn: Medtronic Pelvic Health
Onsite
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week at our Minnesota Rice Creek East facility to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary.
We are looking for a passionate Principal Regulatory Affairs Specialist who has experience developing global regulatory strategies and leading worldwide Clinical Trial Applications (CTA) for our innovative high-risk medical device portfolio.
Role Overview
The Principal Regulatory Affairs Specialist develops global regulatory strategies and leads worldwide clinical trial applications for high-risk medical devices. They will manage strategy meetings and submissions to the FDA, EMA (under EU MDR), discussions with the Notified Body, and coordinates with international regulatory partners for global approvals. Additionally, the specialist develops and executes strategies for new product introductions and lifecycle changes.
Key responsibilities:
- Global Clinical Trial Submissions: Develop, prepare, and manage high-quality clinical trial regulatory dossiers (e.g., IDEs in the US, CTAs in Europe/MDR, ITA in Canada) to obtain approval for initiating clinical studies worldwide.
- Regulatory Strategy: Define and execute global regulatory strategies for high-risk (Class III) devices, providing guidance on pre-clinical and clinical data requirements.
- Agency Interaction: Act as the direct liaison between the company and Regulatory Authorities (FDA, Notified Bodies) or with in-country regulatory partners (Competent Authorities, Health Canada, TGA, etc.) regarding trial applications, amendments, and annual reports.
- Regulatory Intelligence: Monitor, analyze, and communicate changes in global regulations (e.g., EU MDR, FDA, Health Canada, TGA, etc.) affecting clinical research and device development.
- Cross-Functional Collaboration: Partner with Clinical Affairs, R&D, Quality, and Marketing to review clinical protocols, informed consent forms, and investigator brochures for compliance with GCP and local requirements.
- Technical Documentation: Author and review regulatory submission technical dossiers, design history files, and clinical evaluation reports (CERs).
- Product support and maintenance: Support pre- and post-market regulatory activities for high-risk medical devices including:
- Ensuring regulatory compliance (e.g., clinical trial audits, site registrations, device approvals, vigilance reporting, and recalls).
- Supporting the development and review of marketing, advertising, and promotional materials.
- Providing feedback and regulatory guidance to product development teams.
- Managing regulatory support for marketed products, including labeling reviews and change control documentation.
Must Have: Minimum Requirements
- Bachelor’s degree in life science, engineering, or related field with 7 years of relevant experience, or an advanced degree with 5+ years of experience.
- Proven track record of successful high-risk medical device clinical trial applications (e.g., IDE, ITA, CTA) worldwide.
Nice To Have
- 7-10 years of industry experience, with at least 4-5+ years in regulatory, clinical, or quality roles.
- Advanced degree in a scientific, health, or engineering discipline.
- Expert knowledge of global clinical trial authorization regulations, regional risk classifications, and ISO 14155 (GCP) standards.
- Experience with real-world evidence (RWE), AI/ML applications, or digital health technologies.
- Experience in claim development and/or performing advertising and promotion reviews for class III / PMA medical devices.
- Exposure to reimbursement/market access strategies.
- History of successful device submissions in a US Class III PMA environment.
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): $120,000.00 - $180,000.00
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:
Medtronic benefits and compensation plans
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 - 11 May 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
This is an add position with a special focus on developing clinical strategies and clinical study support worldwide. This individual will also perform other regulatory duties.
PRINCIPAL REGULATORY AFFAIRS SPECIALIST – Global Clinical Trials (High-Risk Devices)
Pelvic Health
Our Pelvic Health Operating Unit advances care for patients living with bladder and bowel control conditions through targeted, minimally invasive neuromodulation therapies, including sacral and tibial solutions. Designed to modulate nerve pathways and restore communication between the brain and pelvic floor, these programmable therapies deliver personalized treatment supported by strong clinical evidence and long-term outcomes—helping improve confidence, independence, and quality of life.
Check us out on LinkedIn: Medtronic Pelvic Health
Onsite
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week at our Minnesota Rice Creek East facility to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary.
We are looking for a passionate Principal Regulatory Affairs Specialist who has experience developing global regulatory strategies and leading worldwide Clinical Trial Applications (CTA) for our innovative high-risk medical device portfolio.
Role Overview
The Principal Regulatory Affairs Specialist develops global regulatory strategies and leads worldwide clinical trial applications for high-risk medical devices. They will manage strategy meetings and submissions to the FDA, EMA (under EU MDR), discussions with the Notified Body, and coordinates with international regulatory partners for global approvals. Additionally, the specialist develops and executes strategies for new product introductions and lifecycle changes.
Key responsibilities:
- Global Clinical Trial Submissions: Develop, prepare, and manage high-quality clinical trial regulatory dossiers (e.g., IDEs in the US, CTAs in Europe/MDR, ITA in Canada) to obtain approval for initiating clinical studies worldwide.
- Regulatory Strategy: Define and execute global regulatory strategies for high-risk (Class III) devices, providing guidance on pre-clinical and clinical data requirements.
- Agency Interaction: Act as the direct liaison between the company and Regulatory Authorities (FDA, Notified Bodies) or with in-country regulatory partners (Competent Authorities, Health Canada, TGA, etc.) regarding trial applications, amendments, and annual reports.
- Regulatory Intelligence: Monitor, analyze, and communicate changes in global regulations (e.g., EU MDR, FDA, Health Canada, TGA, etc.) affecting clinical research and device development.
- Cross-Functional Collaboration: Partner with Clinical Affairs, R&D, Quality, and Marketing to review clinical protocols, informed consent forms, and investigator brochures for compliance with GCP and local requirements.
- Technical Documentation: Author and review regulatory submission technical dossiers, design history files, and clinical evaluation reports (CERs).
- Product support and maintenance: Support pre- and post-market regulatory activities for high-risk medical devices including:
- Ensuring regulatory compliance (e.g., clinical trial audits, site registrations, device approvals, vigilance reporting, and recalls).
- Supporting the development and review of marketing, advertising, and promotional materials.
- Providing feedback and regulatory guidance to product development teams.
- Managing regulatory support for marketed products, including labeling reviews and change control documentation.
Must Have: Minimum Requirements
- Bachelor’s degree in life science, engineering, or related field with 7 years of relevant experience, or an advanced degree with 5+ years of experience.
- Proven track record of successful high-risk medical device clinical trial applications (e.g., IDE, ITA, CTA) worldwide.
Nice To Have
- 7-10 years of industry experience, with at least 4-5+ years in regulatory, clinical, or quality roles.
- Advanced degree in a scientific, health, or engineering discipline.
- Expert knowledge of global clinical trial authorization regulations, regional risk classifications, and ISO 14155 (GCP) standards.
- Experience with real-world evidence (RWE), AI/ML applications, or digital health technologies.
- Experience in claim development and/or performing advertising and promotion reviews for class III / PMA medical devices.
- Exposure to reimbursement/market access strategies.
- History of successful device submissions in a US Class III PMA environment.
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): $120,000.00 - $180,000.00
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:
Medtronic benefits and compensation plans
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.
See all 70+ Regulatory Affairs Specialist jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Regulatory Affairs Specialist roles.
Get Access To All JobsTips for Finding TN Visa Sponsorship as a Regulatory Affairs Specialist
Match your credentials to the right TN category
Regulatory Affairs Specialist roles can qualify under Engineer, Chemist, or Scientific Technician depending on your degree and the job duties. Confirm your classification before applying so your credential documentation aligns with what the consular officer or CBP agent will evaluate.
Request a duty-specific offer letter
TN approval hinges on how the employer describes your role. Ask your hiring manager to specify regulatory submission responsibilities, agency liaison duties, and the scientific or technical degree requirement in the letter, not just your job title.
Target employers with existing regulatory teams
Pharmaceutical, medical device, and biotech companies with established regulatory departments are more familiar with TN sponsorship logistics than generalist employers. Focus your search on companies that already file with the FDA, EPA, or Health Canada.
Use Migrate Mate to find sponsoring employers
Search Migrate Mate to identify U.S. employers actively hiring Regulatory Affairs Specialists with TN visa sponsorship. The platform surfaces roles where employers have flagged willingness to sponsor, saving you from cold outreach to companies unfamiliar with USMCA hiring.
Prepare for CBP questions about regulatory scope
Canadian professionals applying at a port of entry should be ready to explain how the role requires theoretical and practical application of a life sciences or engineering discipline, not just administrative compliance work. That distinction matters for TN eligibility.
Understand Mexican citizens' consular processing timeline
If you hold Mexican citizenship, you'll apply through a U.S. consulate rather than at a border crossing. Schedule your consular appointment only after your employer has finalized the offer letter, since the TN is employer-specific and cannot be transferred mid-process.
Regulatory Affairs Specialist jobs are hiring across the US. Find yours.
Find Regulatory Affairs Specialist JobsRegulatory Affairs Specialist TN Visa: Frequently Asked Questions
Does a Regulatory Affairs Specialist role actually qualify for TN visa status?
Yes, but the qualification depends on how the role is structured. TN status typically applies when the position requires a bachelor's degree or higher in a scientific or engineering discipline and involves applying that technical knowledge to regulatory submissions, product compliance, or agency interactions. Roles that are primarily administrative or document-management focused without a scientific foundation are harder to support under TN categories.
How does TN visa sponsorship compare to H-1B for Regulatory Affairs Specialists?
TN is faster and more predictable for this role. There's no lottery, no cap for Canadian citizens, and no multi-month USCIS adjudication wait. Canadian professionals can secure TN status at a port of entry the same day with a valid offer letter. H-1B requires a lottery registration, a cap slot, and USCIS processing that can run six months or longer before you can start work.
What should I look for in an employer's offer letter to support my TN application?
The letter needs to specify the TN category you're applying under, describe duties that demonstrate technical or scientific application rather than general administration, state that the position requires a relevant degree, confirm you're being hired in a professional capacity, and include your anticipated start date and employment duration. Vague job descriptions are the most common reason TN applications stall at the border or consulate.
Where can I find Regulatory Affairs Specialist jobs that include TN visa sponsorship?
Migrate Mate is designed specifically for Canadian and Mexican professionals searching for U.S. roles with TN visa sponsorship. Rather than filtering through general job boards where sponsorship status is unclear, Migrate Mate surfaces positions where employers are already open to USMCA-based hiring, including Regulatory Affairs Specialist roles in pharma, biotech, and medical devices.
Can I switch employers after getting TN status as a Regulatory Affairs Specialist?
Yes, but TN status is employer-specific. Changing jobs requires a new TN authorization tied to the new employer before you stop working for your current one. Canadian citizens can apply for the new TN at a port of entry. Mexican citizens must go back through consular processing. You can't simply transfer your existing TN to a new employer the way some other statuses work.
See which Regulatory Affairs Specialist employers are hiring and sponsoring visas right now.
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