OPT Regulatory Affairs Manager Jobs
Regulatory Affairs Manager jobs on OPT require employers to sponsor work authorization before your OPT period ends. Most roles sit inside pharma, biotech, or medical device companies and expect a degree in life sciences, chemistry, or a related field. STEM OPT extension eligibility is common for this role.
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Get Access To All JobsINTRODUCTION
AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE® probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures.
We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.
Position Summary:
This position will originate appropriate documents to obtain and maintain marketing privileges consistent with applicable government requirements where AtriCure conducts business. This position will also maintain internal documentation of such approvals and handle requests for documentation from our international distributors and customers. This position is responsible for practicing Quality System Manual procedures and complying with its requirements, and carrying out responsibilities as outlined in safety, health and environmental policies.
ESSENTIAL FUNCTIONS OF THE POSITION:
- Support global regulatory pre-market applications for geographies included but not limited to: Taiwan, Singapore, Australia, Brazil, Korea, UAE, EU, UK, U.S, Japan, and Canada. Submission support may include but is not limited to: IDEs, PMA submissions and supplements or 510k for US, EU Technical Documentation, and/or Japan Shonin.
- Support global regulatory post-market activities for the responsible geographies above, such as updating 510(k) letters to file, Technical Files and Design Dossiers on an annual basis, preparing and submitting product renewals, and annual/post-approval reports.
- Support product marketing in additional geographies, as necessary, with international regulatory submissions, product renewals, tender bids, and fulfilling custom requirements.
- Request Certificates to Foreign government and Free Sale Certificates as new products are approved.
- Obtain notarization and legalization of documents as required.
- Maintain, update and track open regulatory requests. Provide periodic status updates on open and closed requests.
- Review of product and manufacturing changes for compliance with applicable regulations (Change Control).
- Work with Regulatory Affairs staff, engineers and technical experts to resolve potential regulatory issues, deficiencies and questions from regulatory agencies.
- Maintain submission correspondence files and other regulatory files in a complete manner.
- Maintain regulatory files for product compliance.
- Perform other related duties as assigned in support of regulatory activities.
- Assist in interacting with reviewers from regulatory agencies on specific projects.
- Provide support during internal and external audits.
- Maintain current knowledge of worldwide regulatory requirements.
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
- Regular and predictable work performance.
- Ability to work under fast-paced conditions.
- Ability to make decisions and use good judgement.
- Ability to prioritize various duties and multitask as required.
- Ability to successfully work with others.
- Additional duties as assigned.
- Hybrid environment (with remote possibilities).
- Travel responsibilities to AtriCure facilities for team functions and activities when needed.
BASIC QUALIFICATIONS:
- Bachelor's degree in a technical/scientific/life science discipline required or 3+ years of Regulatory experience in the medical device industry.
- Proficient on programs within Microsoft Office.
- Written and verbal communication skills.
- Problem solving and/or troubleshooting experience.
PREFERRED QUALIFICATIONS:
- Minimum of 2 years of experience in the medical device industry.
- Basic knowledge of U.S. and/or European/International regulations and standards.
- Strong understanding of documentation within a quality management system.
- Team oriented and able to effectively manage and prioritize multiple projects.
- General knowledge of medical terminology.
OTHER REQUIREMENTS:
- Ability to regularly walk, sit, or stand as needed.
- Ability to occasionally bend and push/pull as needed.
- Ability to pass pre-employment drug screen and background check.
- Occasional travel may be required.
MN Hiring Range:
$85,000-104,000
AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 30 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria.
AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).
INTRODUCTION
AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE® probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures.
We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.
Position Summary:
This position will originate appropriate documents to obtain and maintain marketing privileges consistent with applicable government requirements where AtriCure conducts business. This position will also maintain internal documentation of such approvals and handle requests for documentation from our international distributors and customers. This position is responsible for practicing Quality System Manual procedures and complying with its requirements, and carrying out responsibilities as outlined in safety, health and environmental policies.
ESSENTIAL FUNCTIONS OF THE POSITION:
- Support global regulatory pre-market applications for geographies included but not limited to: Taiwan, Singapore, Australia, Brazil, Korea, UAE, EU, UK, U.S, Japan, and Canada. Submission support may include but is not limited to: IDEs, PMA submissions and supplements or 510k for US, EU Technical Documentation, and/or Japan Shonin.
- Support global regulatory post-market activities for the responsible geographies above, such as updating 510(k) letters to file, Technical Files and Design Dossiers on an annual basis, preparing and submitting product renewals, and annual/post-approval reports.
- Support product marketing in additional geographies, as necessary, with international regulatory submissions, product renewals, tender bids, and fulfilling custom requirements.
- Request Certificates to Foreign government and Free Sale Certificates as new products are approved.
- Obtain notarization and legalization of documents as required.
- Maintain, update and track open regulatory requests. Provide periodic status updates on open and closed requests.
- Review of product and manufacturing changes for compliance with applicable regulations (Change Control).
- Work with Regulatory Affairs staff, engineers and technical experts to resolve potential regulatory issues, deficiencies and questions from regulatory agencies.
- Maintain submission correspondence files and other regulatory files in a complete manner.
- Maintain regulatory files for product compliance.
- Perform other related duties as assigned in support of regulatory activities.
- Assist in interacting with reviewers from regulatory agencies on specific projects.
- Provide support during internal and external audits.
- Maintain current knowledge of worldwide regulatory requirements.
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
- Regular and predictable work performance.
- Ability to work under fast-paced conditions.
- Ability to make decisions and use good judgement.
- Ability to prioritize various duties and multitask as required.
- Ability to successfully work with others.
- Additional duties as assigned.
- Hybrid environment (with remote possibilities).
- Travel responsibilities to AtriCure facilities for team functions and activities when needed.
BASIC QUALIFICATIONS:
- Bachelor's degree in a technical/scientific/life science discipline required or 3+ years of Regulatory experience in the medical device industry.
- Proficient on programs within Microsoft Office.
- Written and verbal communication skills.
- Problem solving and/or troubleshooting experience.
PREFERRED QUALIFICATIONS:
- Minimum of 2 years of experience in the medical device industry.
- Basic knowledge of U.S. and/or European/International regulations and standards.
- Strong understanding of documentation within a quality management system.
- Team oriented and able to effectively manage and prioritize multiple projects.
- General knowledge of medical terminology.
OTHER REQUIREMENTS:
- Ability to regularly walk, sit, or stand as needed.
- Ability to occasionally bend and push/pull as needed.
- Ability to pass pre-employment drug screen and background check.
- Occasional travel may be required.
MN Hiring Range:
$85,000-104,000
AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 30 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria.
AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).
See all 70+ OPT Regulatory Affairs Manager Jobs
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Get Access To All JobsTips for Finding OPT Sponsorship as a Regulatory Affairs Manager
Target STEM-designated programs first
Regulatory Affairs Manager roles frequently fall under STEM OPT extension eligibility. Confirm your degree program's CIP code qualifies before applying, as this gives you up to 24 additional months of work authorization to secure H-1B visa sponsorship.
Focus on regulated industries with established immigration programs
Pharma, biotech, and medical device companies sponsor OPT workers far more consistently than other sectors. These industries have compliance-driven hiring structures and legal teams already familiar with work authorization timelines, making sponsorship conversations less friction-heavy.
Lead with your regulatory credentials in applications
RAC certification, FDA submission experience, or hands-on work with 510(k) or IND filings signals specialized expertise. Employers weigh sponsorship costs against candidate value, so concrete credentials make the business case for sponsoring your visa status stronger.
Time your applications around your OPT expiration window
Apply at least six months before OPT expires so employers have runway to file an H-1B petition or explore cap-exempt options. Hiring managers need time for internal approvals, and compressing that timeline often kills otherwise viable sponsorship conversations.
Understand the specialty occupation argument for your role
Regulatory Affairs Manager qualifies as a specialty occupation because it requires a specific life sciences or engineering degree. Being able to articulate that clearly to a hiring manager removes a common objection and shows you understand the visa process.
Ask about sponsorship policy during the first interview
Raise work authorization early rather than after an offer. Ask specifically whether the company has sponsored H-1B petitions for this role before. A prior sponsorship history in regulatory affairs is the strongest signal that sponsorship is genuinely available.
Regulatory Affairs Manager OPT: Frequently Asked Questions
Does a Regulatory Affairs Manager role qualify for the STEM OPT extension?
It depends on your underlying degree. If your degree is in a STEM-designated field such as biochemistry, biomedical engineering, chemistry, or pharmaceutical sciences, you likely qualify for the 24-month STEM OPT extension. The extension is tied to your degree's CIP code, not your job title. Confirm your program qualifies through your DSO before accepting an offer that depends on the extended timeline.
What types of employers hire Regulatory Affairs Managers on OPT?
Pharmaceutical companies, biotechs, medical device manufacturers, and contract research organizations are the most active sponsors for this role. These employers operate in heavily regulated environments where regulatory affairs expertise is a core business function, not a peripheral one, making them more willing to invest in sponsorship. Browse Migrate Mate to filter specifically for employers that have sponsored OPT workers in this field.
Can I work as a Regulatory Affairs Manager on standard 12-month OPT without a STEM extension?
Yes. Standard OPT authorizes full-time employment in a role related to your degree field, and Regulatory Affairs Manager qualifies if your degree is in life sciences, chemistry, engineering, or a closely related discipline. The practical challenge is that 12 months is a short window for an employer to initiate H-1B sponsorship, so companies with experience sponsoring OPT workers are a better fit than those new to the process.
Does the Regulatory Affairs Manager role qualify as a specialty occupation for H-1B purposes?
Generally yes. The role requires specialized knowledge of regulatory frameworks such as FDA regulations, EU MDR, or ICH guidelines, and a specific bachelor's degree or higher in a related field is the standard entry requirement. USCIS has approved H-1B petitions for regulatory affairs roles consistently, though individual petition outcomes depend on how the employer defines the position in the Labor Condition Application.
What should I do if an employer says they don't sponsor visas for this role?
First, clarify whether they mean H-1B specifically or all work authorization. Some employers are unfamiliar with OPT, which doesn't require them to file a petition and has minimal administrative burden. If they still decline, prioritize employers with a documented sponsorship history. Focusing your search on verified sponsoring employers from the start saves significant time.