Senior Regulatory Affairs SpecialistUnited States of America

Atricure, Inc. • Mason, OH • 1h ago

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. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

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

Support inspections by FDA, notified body, and other regulatory agencies

Monitor and provide management with impact of changes in the Regulatory environment

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

Similar Jobs

Lab Tech

Cincinnati Children's Hospital Medical Center • Middletown, OH • 1h ago

IT & Engineering

JOB RESPONSIBILITIES Schedule: Weekdays 12:30p - 9:00 pm. Rotating every third weekend. Departmental Support - Conduct, direct or assist in special projects, evaluations, experiments or research. Participate in regularly...

1h ago

Go to Apply

Mid-level Traffic Engineer

LJB Inc. • Miamisburg, OH • 1h ago

IT & Engineering

Description Join a Growing National Engineering Firm Shaping the Future of Infrastructure! As a growing, forward-thinking firm, LJB Inc. is expanding our impact across the country by delivering innovative, community-focu...

1h ago

Go to Apply

PSG Tech/RRT I, 18:30-07:00

Cincinnati Children's Hospital Medical Center • Cincinnati, OH • 3h ago

IT & Engineering

JOB RESPONSIBILITIES Assessment - Assesses patients, clients and families and recognizes normal parameters, deviations and abnormalities in physical, emotional, developmental and behavioral status as it relates to cardio...

3h ago

Go to Apply

Electrical Engineer - Utilities and Central Energy

KFI Engineers, P.C. • Cincinnati, OH • 7h ago

IT & Engineering

POSITION SPECIFICATION Position: Electrical Engineer II Department: Utilities & Central Energy (UCE) Reporting Relationship: Senior Project Manager OR Electrical Engineering Manager, UCE COMPANY BACKGROUND KFI Engine...

7h ago

Go to Apply

Engineering Co-op Fall 2026

Duke Energy Ohio, Inc • Cincinnati, OH • 7h ago

IT & Engineering

Important Application Submission Information In order to ensure your application is successfully received before the job posting expires, please submit your application by 11:59 PM on Monday, June 22, 2026 More than a ca...

7h ago

Go to Apply

Database Administrator IV

First Financial Bank • Cincinnati, OH • 11h ago

IT & Engineering

We do the right things, right now. We do them in a way that is relevant to our clients. Become a part of our history as it continues to be written! If you are interested and qualified for this role, we invite you to appl...

11h ago

Go to Apply

Mechanical Engineer - HVAC, Plumbing, Fire Suppression Systems (PE Required)

Rimkus Consulting Group, Inc. • Cincinnati, OH • 11h ago

IT & Engineering

Description Join Rimkus and unlock your potential with endless opportunities for growth, learning, and making a difference! Rimkus (www.rimkus.com) is a worldwide leader in Engineering and Technical Consulting. Rimkus ex...

11h ago

Go to Apply

Forensic Electrical Engineer - Ohio Based

Rimkus Consulting Group, Inc. • Cincinnati, OH • 11h ago

IT & Engineering

Description Join Rimkus and unlock your potential with endless opportunities for growth, learning, and making a difference! Rimkus (www.rimkus.com) is a worldwide leader in engineering and technical consulting. Rimkus ex...

11h ago

Go to Apply

Senior Mechanical Engineer

Atricure, Inc. • Cincinnati, OH • 11h ago

IT & Engineering

11h ago

Go to Apply

Grounds Tech I

Cincinnati Children's Hospital Medical Center • Cincinnati, OH • 16h ago

IT & Engineering

JOB RESPONSIBILITIES Groundskeeping- Restripe all garages and parking lots and special designated areas on CCHMC campus locations. Maintain/ enhance turf areas with proper mowing/ fertilization procedures. Remove snow an...

16h ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)