Regulatory Affairs Specialist - Advertising

Location: Minneapolis, MN
Department: Regulatory
Employment Duration: Full Time Regular
FLSA Status: Exempt
Job Code: 2019-137
Office based or Remote: Office Based

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

 

AtriCure is an Equal Employment Opportunity/Affirmative Action employer. 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).

 

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 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, 15 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/benefits




Agency and Third Party Recruiter Notice:

 

Agencies that submit a resume to AtriCure must have a current Agreement in place, executed by a member of the Human Resource/Recruiting Department. In addition agencies may only submit candidates to positions for which they have been invited to do so by one of our Recruiters or Recruiting Managers. All unsolicited resumes sent to us will be considered property of AtriCure and AtriCure will not be held liable to pay a placement fee.


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