Sr. Regulatory Affairs Specialist

Location: Cincinnati, OH
Department: Regulatory
Employment Duration: Full Time Regular
FLSA Status: Exempt

Description

AtriCure, Inc. is a medical device company that provides innovative solutions designed to decrease the global Afib epidemic. AtriCure’s Isolator® Synergy™ Ablation System is the first and only surgical device approved for the treatment of persistent and longstanding persistent forms of Afib in patients undergoing certain open concomitant procedures. AtriCure’s AtriClip® Left Atrial Appendage Management (LAAM) exclusion device is the most widely sold device worldwide that is indicated for the occlusion of the left atrial appendage. AtriCure believes electrophysiologists and cardiothoracic surgeons are adopting its technologies for the treatment of Afib and reduction of Afib related complications. Afib affects more than 33 million people worldwide. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

 

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 FDA submissions, which may include device 510(k), PMA Supplements, and Design Dossier Amendments 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.

 

Roles and Responsibilities:

  • Prepare written regulatory strategies for new product development and sustaining projects

  • Prepare 510(k) regulatory applications and 510(k) letters to file to secure/maintain marketing approvals

  • Prepare PMA supplements for device or manufacturing changes

  • 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 FDA 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 US regulatory 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

 

BASIC QUALIFICATIONS:

  • B.S. or B.A. degree required

  • A minimum of 5 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

  • 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

 

PREFERRED QUALIFICATIONS:

  • 4 year degree in a technical/scientific discipline

  • Working experience with FDA pre-submissions and PMA submissions

  • Experience with medical capital equipment with embedded software and knowledge of electrical device standards, ie. Electrical Safety (IEC 60601-1) and EMC

 

ESSENTIAL JOB FUNCTIONS (Physical or mental qualification requirement – i.e. walk, sit, stand, bend, push/pull, lift (how much), travel %):

  • 20-30% travel

  • General office work environment

 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, status as an individual with disability, sexual orientation or gender identity.





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