OPT Regulatory Affairs Lead Jobs
Regulatory Affairs Lead roles are a strong fit for F-1 OPT students with backgrounds in life sciences, chemistry, or engineering. Most positions qualify as STEM OPT extensions, giving you up to 36 months of work authorization. Employers in pharma, biotech, and medical devices regularly sponsor 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 Lead Jobs
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Get Access To All JobsTips for Finding OPT Sponsorship in Regulatory Affairs Lead
Target STEM-designated programs
Regulatory Affairs Lead roles typically qualify for the 24-month STEM OPT extension when your degree is in life sciences, chemistry, or engineering. Confirm your degree's CIP code with your DSO before applying to maximize your authorized work period.
Focus on regulated industries
Pharma, biotech, medical device, and food safety companies hire Regulatory Affairs Leads regularly and have established immigration infrastructure. These employers are far more familiar with OPT work authorization than companies in unregulated sectors, reducing friction during hiring.
Highlight submission experience precisely
List specific regulatory submissions you've contributed to, such as 510(k), NDA, BLA, or PMA filings. Employers hiring for a lead role need evidence you can own a submission independently, not just support one.
Address OPT timing proactively
Bring up your OPT end date and STEM extension eligibility early in the process. Regulatory Affairs hiring cycles can run three to six months, and employers need to plan H-1B visa sponsorship timelines around your current authorization window.
Demonstrate knowledge of multiple regulatory bodies
Familiarity with FDA, EMA, Health Canada, or TGA frameworks signals you can support international submissions. Cross-border regulatory experience is increasingly valued and can differentiate your application from candidates with single-agency backgrounds.
Pursue relevant professional credentials
The RAC credential from RAPS is widely recognized and signals regulatory competency to hiring managers. Obtaining or actively pursuing it during OPT strengthens your candidacy and demonstrates commitment to the field beyond your academic background.
Regulatory Affairs Lead OPT: Frequently Asked Questions
Do Regulatory Affairs Lead jobs qualify for the STEM OPT extension?
Most do, but it depends on your underlying degree rather than the job title itself. If your degree carries a STEM-designated CIP code in fields like chemistry, biology, or engineering, and the employer meets the E-Verify requirement, you can apply for the 24-month STEM OPT extension, giving you up to 36 months total. Confirm eligibility with your DSO before accepting an offer.
How do I find Regulatory Affairs Lead roles that are open to OPT students?
Migrate Mate filters job listings specifically for visa-friendly employers, so you can browse Regulatory Affairs Lead openings without wading through postings that exclude work authorization holders. Pharma, biotech, and medical device companies are the most active hirers for this role and are generally experienced with OPT documentation requirements.
Will employers sponsor an H-1B after my OPT ends for this role?
Regulatory Affairs Lead is classified as a specialty occupation under USCIS guidelines because it requires a specific scientific or technical degree, which makes H-1B sponsorship a realistic path. Large pharma and medical device companies sponsor this role regularly. Smaller companies may be willing but less experienced with the process, so it's worth asking directly during interviews.
What should I know about the 60-day grace period if a Regulatory Affairs Lead job falls through?
If your employment ends before your OPT period expires, you have a 60-day grace period to find new employment, transfer to a new visa status, or depart the United States. You cannot work during this window. Given that Regulatory Affairs hiring cycles can take several months, notify your DSO immediately so you can plan your next steps before the clock runs out.
Is a Regulatory Affairs Lead role considered a specialty occupation for OPT purposes?
OPT itself doesn't use the specialty occupation standard, but the role must be directly related to your field of study to qualify as authorized OPT employment. A Regulatory Affairs Lead position drawing on your chemistry, pharmacy, or biomedical engineering degree clearly satisfies this. Your DSO can confirm the match between your CIP code and the role's requirements if you need documentation.