Regulatory Affairs Manager
|Employment Duration:||Full Time Regular|
|Office based or Remote:||Office Based|
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.
The Regulatory Affairs Manager is responsible for AtriCure’s regulatory submission programs to obtain and maintain marketing privileges consistent with applicable government requirements where AtriCure conducts business. The Regulatory Affairs Manager must identify regulatory requirements and assess and communicate such requirements, submission strategies and risks to the organization. The Regulatory Affairs Manager will interface with relevant global regulatory authorities and notified bodies to support company regulatory/compliance goals. The Regulatory Affairs Manager will be responsible for: preparation and submission of FDA submissions, which may include pre-market approval (PMA) applications, investigational device exemption (IDE) applications, Q-submissions, 510(k) pre-market notifications, PMA Supplements; Design Dossiers and Amendments; Notified Body notifications; registration with competent authorities and regulatory bodies; maintenance of Technical Files; and/or other regulatory submissions to support business growth. The Regulatory Affairs Manager will serve as regulatory representative on selected projects for clinical, new product development, or line extension. Additionally, the Regulatory Affairs Manager will supervise a team of regulatory affairs professionals and will provide support and training to junior level members of the Regulatory Affairs team.
ESSENTIAL FUNCTIONS OF THE POSITION:
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
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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