Regulatory Affairs Specialist

Atricure, Inc. Cincinnati , OH 45201

Posted 2 months ago

Position/Title:

Regulatory Affairs Specialist

Department:

Regulatory Affairs

Reports To:

Manager, Regulatory Affairs, or Director, Regulatory Affairs

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:

This position will originate appropriate documents to obtain and maintain marketing privileges consistent with applicable government requirements where AtriCure conducts business. This position will also maintain internal documentation of such approvals. This position 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:

  • Support 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

  • Assist with preparation of PMA supplements and annual reports for device or manufacturing changes

  • Create and submit international regulatory submissions for worldwide marketing approvals including Design Dossiers and Technical Files for the EU.

  • Prepare appropriate documentation for CE mark renewals, and updating technical files and design dossiers on an annual basis

  • 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

  • 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

  • Maintain regulatory files for product compliance

  • Maintain current knowledge base on existing and emerging regulations, standards, and guidance documents and apply them to change control sign-offs

  • Perform other related duties as assigned in support of regulatory activities

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

  • Regular and predictable worksite attendance

  • 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 required or 5+ years of Regulatory experience in the medical device industry

  • Computer and data entry skills

  • Written and verbal communication skills

  • Problem solving and/or troubleshooting experience

  • Ability to travel 10%

PREFERRED QUALIFICATIONS:

  • Strong understanding of the administrative aspects of document management

  • Team oriented and able to effectively manage and prioritize multiple projects

  • General knowledge of medical terminology

  • Excellent organizational and computer skills (presentation slide decks, word processing, spreadsheets, and databases)

OTHER REQUIREMENTS:

  • Ability to regularly walk, sit, or stand as required

  • Ability to occasionally bend and push/pull

  • Ability to occasionally lift up to 25 pounds

  • Ability to pass pre-employment drug screen and background check

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).

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


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Regulatory Affairs Specialist

Atricure, Inc.