Regulatory Affairs Specialist

Posting Date: 03/12/2019
Closing Date: 06/12/2019
Posting Level:


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 and we have treated over 200,000 patients over the past ten years. Additionally, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide, with more than 130,000 implanted to date. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.



Position Summary:

The Regulatory Affairs Specialist is responsible for developing regulatory strategies, preparing regulatory submissions, and obtaining approvals necessary to introduce new or revised products and therapies to markets worldwide. Directly prepares international regulatory submissions and provides timely response to competent authority questions in support of product approvals. Works to ensure all information provided is correct and accurate.

Roles and Responsibilities:

•Research and propose global regulatory strategies for new products and postmarket changes.


•Prepare 510(k) regulatory applications and 510(k) letters to file for internal review and submission to FDA to secure/maintain U.S. marketing approvals.


•Create international regulatory submissions for worldwide marketing approvals for internal review and submission, including Design Dossiers and Technical Files for the EU, Canadian and Australian applications.


•Prepare appropriate documentation for renewing CE mark certification.


•Work with Regulatory Affairs staff, engineers and technical experts to resolve potential regulatory issues, deficiencies and questions from regulatory agencies.


•Keep up-to-date with changing regulations and educate cross functional peers on new medical device regulations, such as EU MDR.


•Regulatory representative on select project teams.


•Review documents required for submissions to emerging markets to ensure they are appropriate for submission.


•Maintain, update and track open OUS regulatory requests. Provide monthly status on open and closed requests.


•Provide support for current marketed products as necessary. This includes product renewals, tender bids and customs requirements


•Other duties as assigned in support of regulatory activities.




BASIC QUALIFICATIONS:

•Undergraduate degree or 5 years of industry experience.


•Strong written and verbal communication skills.


•Problem solving and/or troubleshooting experience.


•Computer and data entry skills.




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 (word processing, spreadsheets, databases).




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

•0-15% 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.


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



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