TN Visa Risk And Compliance Jobs
Risk and compliance roles qualify for TN visa sponsorship under the USMCA treaty for Canadian and Mexican professionals with a relevant bachelor's degree. Employers file no lottery and face no annual cap for Canadians, making sponsorship faster than H-1B visa. Mexican professionals are subject to a separate TN allocation.
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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.
The Opportunity
This position works out of our corporate Abbott Park, Illinois location or other applicable Abbott location. The Abbott Quality and Regulatory (AQR) Global compliance audit function is a corporate program which conducts audits of Quality Systems across all of Abbott's Manufacturing sites.
Product quality and/or regulatory problems can negatively affect consumer health and safety, Abbott’s worldwide image, performance of Abbott earnings and market share and customer confidence and loyalty. The role has a broad responsibility that has significant impact throughout AQR and all divisions. The position is responsible for ensuring executive management is aware of compliance business risks and regulatory requirements.
We are seeking an experienced Senior Medical Device Software Risk and Compliance Auditor with specialized expertise in auditing medical device software to protect patient safety and ensure compliance with regulatory requirements, industry standards, and internal policies. This role involves conducting technical audits across the software development lifecycle, assessing adherence to quality management systems, and supporting continuous improvement initiatives for product software including SAMD, SIMD, Non product software and cloud based applications.
As a Senior Software Risk and Compliance Auditor, you will lead Quality System audits and assessments according to regulations, standards and Abbott procedures.
You will participate in cross-divisional activities to integrate information from compliance audits, assessments and regulatory trends that may impact Divisions.
The responsibility of the role includes proactive determination of regulatory, compliance, and quality issues, to integrate them into audits and assessments. The role requires very effective communication and decision making with all levels of management as well as other division and corporate departments. The incumbent must be able to work independently without direct supervision or guidance and to exercise judgment in determining when complex issues merit Corporate Management involvement. Decisions must be made based on up-to-date regulatory knowledge, technical/business knowledge and skills.
What You’ll Work On
- Work independently to direct, plan, develop and implement audit policies and programs for systems division-wide.
- Lead in-depth risk based Quality System audits with focus on Product and Non Product Software including apps across Abbott manufacturing sites.
- Plan, execute, and report on internal audits including in-depth analysis on medical device software development and validation processes.
- Evaluate compliance with global regulations including FDA 21 CFR Part 11, FDA 21 CFR Part 820, ISO 13485, IEC 62304, GAMP5 CSV and other applicable regulations and standards.
- Monitor emerging regulatory requirements, industry trends and competitor analysis to develop audit strategies and identify products or processes which require focused audits.
- Maintain up-to-date knowledge of evolving regulations and best practices in medical device software compliance.
- Review software documentation, risk management files, and validation protocols for technical completeness and compliance.
- Identify non-conformities, product and process risks, and areas for improvement.
- Write professional audit reports for executive management.
- Communicate effectively to articulate risks and associated impact to all levels of management.
- Develop and provide professional education on compliance and quality topics that are key to Abbott businesses.
- Develop risk based audit program with oversight for auditing of product and non product software including development of Abbott wide auditor training and competency assessments.
- Analyse compliance risks and communicate trends and opportunities to senior leadership and corporate policy makers.
- Promote and apply best-practice analysis and auditing tools, understanding their constraints, advantages, and disadvantages, and ensuring adherence to established standards.
- Promote continuous learning and improvement within the audit team.
Required Qualifications
- Four-year degree in a scientific, technical or compliance discipline or equivalent experience.
- Lead auditor certificate for Quality System audits desirable.
Required Skills
- In-depth knowledge of global software standards and regulations including IEC 62304, ISO 13485, ISO 14971, GAMP 5 CSV and FDA software validation guidance.
- Strong analytical and problem-solving skills with attention to detail.
- Very effective oral and written communication, critical thinking and decision making skills.
- Ability to manage multiple audits and prioritize effectively.
- Proficiency in audit tools and techniques; certifications such as ISO Lead Auditor are desirable.
- Effective time management skills.
Preferred Experience
- 10+ years in software design and development in the medical device industry.
- Proven track record working on software development and software lifecycle programs including:
- Software as a medical device
- Software within a medical device
- Cloud based applications
- Non product software
- Cybersecurity
- Artificial Intelligence
- Strong understanding of Quality Management Systems (QMS) and software lifecycle standards.
- Experience with risk based auditing and familiarity with GxP principles desirable.
- Experience with product submissions or regulatory audits desirable.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
The base pay for this position is $129,300.00 – $258,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY: Operations Quality
DIVISION: AQR Abbott Quality and Regulatory
LOCATION: United States > Abbott Park : AP01A
WORK SHIFT: Standard
TRAVEL: Yes, 50 % of the Time
MEDICAL SURVEILLANCE: No
SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
JOB DESCRIPTION:
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.
The Opportunity
This position works out of our corporate Abbott Park, Illinois location or other applicable Abbott location. The Abbott Quality and Regulatory (AQR) Global compliance audit function is a corporate program which conducts audits of Quality Systems across all of Abbott's Manufacturing sites.
Product quality and/or regulatory problems can negatively affect consumer health and safety, Abbott’s worldwide image, performance of Abbott earnings and market share and customer confidence and loyalty. The role has a broad responsibility that has significant impact throughout AQR and all divisions. The position is responsible for ensuring executive management is aware of compliance business risks and regulatory requirements.
We are seeking an experienced Senior Medical Device Software Risk and Compliance Auditor with specialized expertise in auditing medical device software to protect patient safety and ensure compliance with regulatory requirements, industry standards, and internal policies. This role involves conducting technical audits across the software development lifecycle, assessing adherence to quality management systems, and supporting continuous improvement initiatives for product software including SAMD, SIMD, Non product software and cloud based applications.
As a Senior Software Risk and Compliance Auditor, you will lead Quality System audits and assessments according to regulations, standards and Abbott procedures.
You will participate in cross-divisional activities to integrate information from compliance audits, assessments and regulatory trends that may impact Divisions.
The responsibility of the role includes proactive determination of regulatory, compliance, and quality issues, to integrate them into audits and assessments. The role requires very effective communication and decision making with all levels of management as well as other division and corporate departments. The incumbent must be able to work independently without direct supervision or guidance and to exercise judgment in determining when complex issues merit Corporate Management involvement. Decisions must be made based on up-to-date regulatory knowledge, technical/business knowledge and skills.
What You’ll Work On
- Work independently to direct, plan, develop and implement audit policies and programs for systems division-wide.
- Lead in-depth risk based Quality System audits with focus on Product and Non Product Software including apps across Abbott manufacturing sites.
- Plan, execute, and report on internal audits including in-depth analysis on medical device software development and validation processes.
- Evaluate compliance with global regulations including FDA 21 CFR Part 11, FDA 21 CFR Part 820, ISO 13485, IEC 62304, GAMP5 CSV and other applicable regulations and standards.
- Monitor emerging regulatory requirements, industry trends and competitor analysis to develop audit strategies and identify products or processes which require focused audits.
- Maintain up-to-date knowledge of evolving regulations and best practices in medical device software compliance.
- Review software documentation, risk management files, and validation protocols for technical completeness and compliance.
- Identify non-conformities, product and process risks, and areas for improvement.
- Write professional audit reports for executive management.
- Communicate effectively to articulate risks and associated impact to all levels of management.
- Develop and provide professional education on compliance and quality topics that are key to Abbott businesses.
- Develop risk based audit program with oversight for auditing of product and non product software including development of Abbott wide auditor training and competency assessments.
- Analyse compliance risks and communicate trends and opportunities to senior leadership and corporate policy makers.
- Promote and apply best-practice analysis and auditing tools, understanding their constraints, advantages, and disadvantages, and ensuring adherence to established standards.
- Promote continuous learning and improvement within the audit team.
Required Qualifications
- Four-year degree in a scientific, technical or compliance discipline or equivalent experience.
- Lead auditor certificate for Quality System audits desirable.
Required Skills
- In-depth knowledge of global software standards and regulations including IEC 62304, ISO 13485, ISO 14971, GAMP 5 CSV and FDA software validation guidance.
- Strong analytical and problem-solving skills with attention to detail.
- Very effective oral and written communication, critical thinking and decision making skills.
- Ability to manage multiple audits and prioritize effectively.
- Proficiency in audit tools and techniques; certifications such as ISO Lead Auditor are desirable.
- Effective time management skills.
Preferred Experience
- 10+ years in software design and development in the medical device industry.
- Proven track record working on software development and software lifecycle programs including:
- Software as a medical device
- Software within a medical device
- Cloud based applications
- Non product software
- Cybersecurity
- Artificial Intelligence
- Strong understanding of Quality Management Systems (QMS) and software lifecycle standards.
- Experience with risk based auditing and familiarity with GxP principles desirable.
- Experience with product submissions or regulatory audits desirable.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
The base pay for this position is $129,300.00 – $258,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY: Operations Quality
DIVISION: AQR Abbott Quality and Regulatory
LOCATION: United States > Abbott Park : AP01A
WORK SHIFT: Standard
TRAVEL: Yes, 50 % of the Time
MEDICAL SURVEILLANCE: No
SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
See all 42+ TN Visa Risk And Compliance Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new TN Visa Risk And Compliance Jobs.
Get Access To All JobsTips for Finding TN Visa Sponsorship in Risk And Compliance
Align your credentials to compliance SOC codes
TN visa eligibility for risk and compliance roles hinges on your degree field matching the position. A finance or business law degree supports a compliance analyst role more cleanly than a general management degree, which CBP officers may scrutinize.
Target employers experienced with visa sponsorship
Financial institutions, insurance carriers, and multinational corporations in regulated industries have recent visa filings and understand work visa sponsorship processes. Prioritize employers whose legal or HR teams are experienced with visa sponsorship, as they're more likely to understand the documentation requirements for compliance-specific job titles and be prepared to provide the support letter needed for TN visa applications.
Negotiate the offer letter before filing begins
Your offer letter must specify the exact TN occupational category and describe duties that align with it. Risk and compliance job descriptions that mix in unqualified management tasks can trigger CBP questions at the port of entry.
Search TN-sponsoring employers using Migrate Mate
Use Migrate Mate to filter risk and compliance roles by employers with active TN visa sponsorship history, saving time you'd otherwise spend cold-emailing HR teams who aren't familiar with TN filings for this occupational category.
Prepare a degree equivalency letter for Mexican applicants
Mexican professionals with a licenciatura in accounting, law, or finance should obtain a credential evaluation confirming U.S. degree equivalency before applying. CBP officers at land ports sometimes request this documentation for compliance-category TN entrants.
Request premium processing if your start date is fixed
Canadian citizens can use USCIS Form I-129 with premium processing to get a 15-business-day decision when a port-of-entry admission isn't feasible. This route is especially useful if your employer's compliance team has a hard onboarding deadline.
Risk And Compliance TN Visa: Frequently Asked Questions
Does a risk and compliance role qualify for TN visa status?
Yes, if the position maps to an eligible USMCA occupational category such as accountant, economist, or financial analyst and requires at least a bachelor's degree in a related field. Job titles that mix compliance duties with generalist management responsibilities may face CBP scrutiny, so your offer letter should clearly describe the specialized compliance function.
How does TN visa sponsorship compare to H-1B for compliance professionals?
TN has no lottery and no annual cap for Canadians, so sponsorship can happen year-round without waiting for an October start date. H-1B requires employer sponsorship through a competitive lottery with a roughly 25% selection rate. For compliance roles that clearly fit a USMCA-defined occupation, TN is a faster and more predictable path than H-1B.
Where can I find employers that sponsor TN visas for risk and compliance roles?
Migrate Mate lets you search risk and compliance job listings filtered by employers with TN visa sponsorship history. This removes the guesswork of identifying which financial institutions and corporate compliance teams are already familiar with TN filings for this occupational category.
Can a Mexican compliance professional qualify for TN status the same way a Canadian can?
The eligibility requirements are the same, but Mexican TN applicants must apply through a U.S. consulate rather than at a port of entry. Mexico also has a separate TN allocation under the USMCA. Credential documentation, including a degree equivalency evaluation if your licenciatura is not immediately recognized, is especially important for consular applications.
What happens to my TN status if my employer terminates my compliance role?
Your TN status is tied to the specific employer and role on your admission record. If your position ends, you are expected to depart the U.S. or secure a new TN with a different employer. There is no formal grace period codified for TN holders the way there is for H-1B, so coordinating a new offer quickly is essential.