Senior Regulatory Affairs Specialist

AtriCure; Glendale (OH); On-site; USD 106,000 - 130,000; Full time

Benefits offered by this job

Medical & Dental beginning day 1

401K plus match

Parental Leave

Volunteer Time off

Pet Insurance

Job summary

AtriCure, Inc. is seeking a Senior Regulatory Affairs Specialist to originate documents and submit regulatory filings worldwide to support market approvals. This role will coordinate US 510(k) and PMA activities and oversee international submissions while ensuring post‑market compliance.

The position requires collaboration with cross‑functional teams, strong technical writing, and the ability to manage multiple regulatory projects across regions, including FDA interactions and global guidelines.

Qualifications

• Bachelor’s degree or demonstrated equivalent combination of education and experience.
• 4+ years of regulatory affairs experience for medical devices.
• Knowledge of US and/or EU/International regulations and standards.
• Experience preparing regulatory submissions and interacting with FDA or other agencies.
• Strong technical writing, teamwork and communication skills.
• Proficient with Microsoft Office; awareness of manufacturing and change control.
• Ability to travel 10–15%.

Responsibilities

• Prepare regulatory strategies for new development and sustaining projects.
• Prepare US submissions including 510(k) and PMA; draft 510(k) letters.
• Prepare EU, Canada, Australia, Brazil, Japan submissions or change notifications.
• Represent Regulatory Affairs on cross‑functional teams and support Design Control.
• Provide regulatory support for risk management and clinical evaluation.
• Develop strategies for new or modified products and assist planning.
• Serve as liaison with FDA, EU Notified Bodies and other agencies.
• Collaborate with regional personnel on global product registrations.
• Support inspections and audits by regulatory bodies.
• Monitor regulatory changes and apply to change control sign-offs.
• Coordinate submissions with milestones and sign-off responsibility.

Skills

Regulatory strategy

Technical writing

Team collaboration

Regulatory trends

Microsoft Office

Education

Bachelor's degree

Technical/scientific degree

Tools

Microsoft Office

Job description

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
• 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

Positions in Minnesota

Minnesota pay range

$106,000 — $130,000 USD

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. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/careers-atricure/benefits

AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov 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).

You may access our global privacy policy here: https://www.atricure.com/privacy

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