AtriCure Job - 30396984 | CareerArc
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Company: AtriCure
Location: Minneapolis, MN
Career Level: Associate
Industries: Healthcare, Pharmaceutical, Biotech

Description

AtriCure, Inc. provides innovative technologies for the treatment of Atrial Fibrillation (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 and only medical device to receive FDA approval for the treatment of long standing persistent Afib. Additionally, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

POSITION SUMMARY:

The Regulatory Affairs Specialist position will include coordinating and maintaining promotional and commercial material review process by interacting with marketing and clinical training functional departments. Secondarily, originate submission documents to obtain and maintain marketing licenses consistent with applicable government requirements where AtriCure conducts business.

The Regulatory Affairs Specialist is responsible for practicing Quality System Manual procedures and complying with its requirements, and carrying out responsibilities as outlined in safety, health and environmental policies.

ESSENTIAL FUNCTIONS OF THE POSITION:

  • Triage marketing and training material for regulatory review and compliance.
  • Assist with conducting weekly material review meetings and record meetings for audits
  • Assist with promotional and commercial material storage and prepare
  • Assist with multiple PMA regulatory marketing launch material planning and execution
  • Assist in department standard operating procedure creation and maintenance
  • Assist in supporting audit and compliance activities
  • Prepare, archive and maintain marketing approvals
  • Create and submit international regulatory submissions for worldwide marketing approvals
  • Work with Regulatory Affairs staff, engineers and technical experts to resolve potential regulatory issues, deficiencies and questions from regulatory agencies
  • Maintain submission correspondence files and other regulatory files in a complete manner
  • 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:

  • Ability to work under fast-paced conditions
  • Ability to make decisions and use good judgment
  • Ability to prioritize various duties and multitask as required
  • Ability to successfully work with others
  • Additional duties as assigned

BASIC QUALIFICATIONS:

  • Bachelor's degree in a technical/scientific discipline
  • Experience in the medical device industry or medical environment
  • Computer and data entry skills
  • Written and verbal communication skills
  • Problem solving and/or troubleshooting experience
  • Ability to travel 10%

PREFERRED QUALIFICATIONS:

  • Knowledge of U.S. and/or European/International regulations and standards
  • Experience in preparing regulatory submissions
  • Experience with cardiac medical devices

OTHER REQUIREMENTS:

  • Ability to regularly walk, sit, or stand as required
  • Ability to occasionally bend and push/pull
  • Ability to pass pre-employment drug screen and background check


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