Medical Devices Visa Sponsorship Jobs in Ohio
Ohio's medical devices industry centers around major innovation hubs in Cleveland, Columbus, and Cincinnati. Leading companies like Cardinal Health, Abbott Laboratories, and Battelle Memorial Institute actively sponsor international talent for engineering, regulatory affairs, and R&D positions. The state's strong healthcare infrastructure and proximity to top medical schools create consistent demand for specialized professionals.
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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:
The Senior Regulatory Affairs Specialist originates appropriate documents to obtain and maintain marketing privileges consistent with applicable government requirements where AtriCure conducts business. This position will prepare and submit submissions, which may include US device 510(k), PMA Supplements, EU, Canada, Australia, Brazilian, Japanese, and other international submissions to support business growth. The position will serve as regulatory representative on selected projects for new product development or line extension and will provide regulatory supervision on post-market product changes to maintain marketing approvals.
ESSENTIAL FUNCTIONS OF THE POSITION:
- Prepare written regulatory strategies for new product development and sustaining projects
- Prepare US submissions as necessary including 510(k) regulatory applications, PMA supplements for device and manufacturing, drafting 510(k) letters to file to secure/maintain marketing approvals
- Prepare EU, Canada, Australia, Brazilian, Japanese, and other international submissions or notifications of change when necessary
- Represent Regulatory Affairs as core team member of new product development projects to drive innovation and to support Design Control process
- Provide Regulatory support for risk management activities and clinical evaluation
- Develop Regulatory Strategies for new or modified products and assist on project planning
- Act as the Regulatory liaison with key agency stakeholders including FDA, EU Notified Body, Health Canada, and other government agencies on behalf of the organization to facilitate timely and favorable review of submissions and pre-submission activity
- Collaborate with regional regulatory personnel on assessing and documenting the global impact of product change on product registration and license globally
- Assist in development/maintenance of regulatory operational practices
- Supports inspections and audits by FDA, notified body, and other regulatory agencies
- Monitor and provide management with impact of changes in the Regulatory environment
- Conducts reviews and provides input to the development of technical documentation including test reports across multiple disciplines including sterilization, biocompatibility, and electrical safety
- Plans coordinate and compile submissions with minimal review and with sign-off responsibility
- Demonstrate strong working knowledge of global laws, regulations, guidelines, and standards related to commercialization and post market surveillance
- Maintain current knowledge base on existing and emerging regulations, standards, and guidance documents and apply them to change control sign-offs
- Independently manage multiple projects, department initiatives, and day-to-day tasks
- Demonstrate strong working knowledge of clinical technical concepts and applications related to commercialized products
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
- Ability to coordinate projects, track milestones and communicate progress to stakeholder
BASIC QUALIFICATIONS:
- Bachelor's degree required or demonstrated equivalent combination of education, training and experience
- A minimum of 4 years of regulatory affairs working experience, mainly for medical devices
- Must have knowledge of U.S. and/or European/International regulations and standards
- Experience in preparing regulatory submissions; Experience interacting with FDA and/or other regulatory agencies
- Provide examples of past approvals/clearances with regulatory agencies
- Must demonstrate good technical writing skill; Must work well in team environments; Must demonstrate good communication skill in team setting
- Proficient on programs within Microsoft Office; Proven analytical abilities, Solid understanding of manufacturing and change control, and an awareness of regulatory trends
- Ability to travel 10-15%
PREFERRED QUALIFICATIONS:
- 4-year degree in a technical/scientific discipline
- Working experience with cardiac devices, including capital equipment
- Experience with medical capital equipment with embedded software and knowledge of electrical device standards, ie. Electrical Safety (IEC 60601-1) and EMC
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
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:
The Senior Regulatory Affairs Specialist originates appropriate documents to obtain and maintain marketing privileges consistent with applicable government requirements where AtriCure conducts business. This position will prepare and submit submissions, which may include US device 510(k), PMA Supplements, EU, Canada, Australia, Brazilian, Japanese, and other international submissions to support business growth. The position will serve as regulatory representative on selected projects for new product development or line extension and will provide regulatory supervision on post-market product changes to maintain marketing approvals.
ESSENTIAL FUNCTIONS OF THE POSITION:
- Prepare written regulatory strategies for new product development and sustaining projects
- Prepare US submissions as necessary including 510(k) regulatory applications, PMA supplements for device and manufacturing, drafting 510(k) letters to file to secure/maintain marketing approvals
- Prepare EU, Canada, Australia, Brazilian, Japanese, and other international submissions or notifications of change when necessary
- Represent Regulatory Affairs as core team member of new product development projects to drive innovation and to support Design Control process
- Provide Regulatory support for risk management activities and clinical evaluation
- Develop Regulatory Strategies for new or modified products and assist on project planning
- Act as the Regulatory liaison with key agency stakeholders including FDA, EU Notified Body, Health Canada, and other government agencies on behalf of the organization to facilitate timely and favorable review of submissions and pre-submission activity
- Collaborate with regional regulatory personnel on assessing and documenting the global impact of product change on product registration and license globally
- Assist in development/maintenance of regulatory operational practices
- Supports inspections and audits by FDA, notified body, and other regulatory agencies
- Monitor and provide management with impact of changes in the Regulatory environment
- Conducts reviews and provides input to the development of technical documentation including test reports across multiple disciplines including sterilization, biocompatibility, and electrical safety
- Plans coordinate and compile submissions with minimal review and with sign-off responsibility
- Demonstrate strong working knowledge of global laws, regulations, guidelines, and standards related to commercialization and post market surveillance
- Maintain current knowledge base on existing and emerging regulations, standards, and guidance documents and apply them to change control sign-offs
- Independently manage multiple projects, department initiatives, and day-to-day tasks
- Demonstrate strong working knowledge of clinical technical concepts and applications related to commercialized products
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
- Ability to coordinate projects, track milestones and communicate progress to stakeholder
BASIC QUALIFICATIONS:
- Bachelor's degree required or demonstrated equivalent combination of education, training and experience
- A minimum of 4 years of regulatory affairs working experience, mainly for medical devices
- Must have knowledge of U.S. and/or European/International regulations and standards
- Experience in preparing regulatory submissions; Experience interacting with FDA and/or other regulatory agencies
- Provide examples of past approvals/clearances with regulatory agencies
- Must demonstrate good technical writing skill; Must work well in team environments; Must demonstrate good communication skill in team setting
- Proficient on programs within Microsoft Office; Proven analytical abilities, Solid understanding of manufacturing and change control, and an awareness of regulatory trends
- Ability to travel 10-15%
PREFERRED QUALIFICATIONS:
- 4-year degree in a technical/scientific discipline
- Working experience with cardiac devices, including capital equipment
- Experience with medical capital equipment with embedded software and knowledge of electrical device standards, ie. Electrical Safety (IEC 60601-1) and EMC
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
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).
Medical Devices Job Roles in Ohio
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Search Medical Devices Jobs in OhioMedical Devices Jobs in Ohio: Frequently Asked Questions
Which medical devices companies sponsor visas in Ohio?
Major medical devices employers in Ohio that sponsor visas include Cardinal Health (Dublin), Abbott Laboratories (Columbus), Battelle Memorial Institute (Columbus), and Steris Corporation (Mentor). Regional companies like Invacare Corporation and smaller biomedical startups near Case Western Reserve University and Ohio State University also sponsor H-1B visa and other work visas for specialized engineering and regulatory roles.
Which cities in Ohio have the most medical devices sponsorship jobs?
Columbus leads Ohio's medical devices job market with major companies like Cardinal Health and Abbott, followed by Cleveland with its strong medical research institutions and companies like Steris. Cincinnati offers opportunities through its healthcare network, while Dayton and Toledo have growing medical technology sectors with smaller but active sponsorship opportunities.
How to find medical devices visa sponsorship jobs in Ohio?
Use Migrate Mate to search specifically for medical devices positions in Ohio that offer visa sponsorship. Filter by cities like Columbus, Cleveland, and Cincinnati, and focus on roles at established companies like Cardinal Health, Abbott, and Battelle. Many positions require biomedical engineering, regulatory affairs, or quality assurance expertise with relevant degree requirements for specialty occupation visas.
Which visa types are most common for medical devices roles in Ohio?
H-1B visas dominate medical devices sponsorship in Ohio, particularly for biomedical engineers, regulatory specialists, and R&D scientists. O-1 visas are used for senior researchers and executives at major companies like Cardinal Health and Abbott. TN visas serve Canadian and Mexican professionals, while L-1 visas facilitate transfers within multinational medical devices corporations operating in Ohio.
What are the prevailing wage considerations for medical devices jobs in Ohio?
Ohio's medical devices prevailing wages vary by location, with Columbus and Cleveland commanding higher rates than smaller cities. Biomedical engineers and regulatory affairs specialists typically qualify for Level 2-3 wages under Department of Labor standards. The state's lower cost of living compared to coastal states can make Ohio positions attractive even with competitive but not premium wage levels.
What is the prevailing wage for sponsored medical devices jobs in Ohio?
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.