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, 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 …
Skills: Process engineering, Manufacturing processes, Lean manufacturing, Six Sigma, Root cause analysis
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, 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 …
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$106k–$130k/yr
Full-time
bachelor degree
Medical insurance, Dental insurance, 401k with match, Paid parental leave, Maternity leave, Volunteer time off
Posted 9d ago
~40 hrs/week
Responsibilities
The Senior Regulatory Affairs Specialist prepares and submits regulatory documentation to obtain and maintain global marketing privileges for medical devices. They also serve as a regulatory representative on product development teams to ensure compliance with design controls and international standards.
Requirements
Candidates must possess a bachelor's degree and at least 4 years of regulatory affairs experience, specifically within the medical device industry. Strong technical writing skills and proven experience in preparing regulatory submissions for agencies like the FDA are required.
Full 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
#LI-JH
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).
We are passionately focused on healing the lives of those affected by Afib and pain after surgery.
Industry
Medical Equipment Manufacturing
Company size
1,001-5,000 employees
Founded
2000
Headquarters
Mason, Ohio
LinkedIn followers
53,943
Total funding
$207M
AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 37 million people worldwide.
Electrophysiologists, cardiothoracic and thoracic surgeons around the globe use AtriCure technologies for the treatment of Afib, reduction of Afib related complications and post-operative pain management. 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®+ and cryoSPHERE MAX™ probes are 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 X (formerly Twitter) @AtriCure.
Offices: 7555 Innovation Way, Mason, Ohio 45040, US · 130 Cheshire Ln, Suite 250, Minnetonka, Minnesota 55305, US · 3875 Hopyard Rd, Unit 160, Pleasanton, California 94588, US · De Entree, 260, Amsterdam, North Holland 1101, NL · 3A Chater Road, Level 16, The Hong Kong Club Building, Central, HK
Medical DevicesManufacturingAtrial Fibrillationand Maze IV TrainingHealth CareMedical DeviceBiotechnologyMedical
How many Engineering jobs are open in Mason, OH right now?
There are currently 167 open engineering positions in Mason, OH listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Engineering roles in Mason, OH?
Companies currently hiring include Hi-Tek Manufacturing, Inc., SPX Technologies, L3Harris Technologies, AtriCure, Inc., Lincoln Electric, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Engineering jobs in Mason, OH?
Yes — 7 of the 167 open engineering positions offer remote or hybrid work (1 remote, 6 hybrid).
How do I apply for Engineering jobs in Mason, OH?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.