Senior Regulatory Affairs Specialist

About this role

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 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

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…