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:
•Supervise and mentor a team of regulatory affairs professionals.
•Prepare written regulatory strategies for regulatory and notified body submissions, clinical trials, new product development, and sustaining projects.
•Prepare new PMA and IDE regulatory applications.
•Prepare 510(k) pre-market notification applications and letters to file to secure/maintain marketing clearances.
•Prepare PMA supplements for design or manufacturing changes.
•Prepare Notified Body submissions and notifications.
•Register AtriCure products with appropriate regulatory bodies.
•Represent Regulatory Affairs as core team member of clinical and new product development projects to drive innovation and to support Design Control process.
•Provide Regulatory support for risk management activities and clinical evaluation.
•Develop Regulatory Strategies for new or modified products and assist on project planning.
•Act as the Regulatory liaison with FDA on behalf of the organization to facilitate timely and favorable review of regulatory submissions.
•Collaborate with regional regulatory personnel on assessing and documenting the global impact of product change on product registration and license globally.
•Assist in development and maintenance of regulatory operational practices.
•Support inspections by FDA, notified body, and other regulatory agencies.
•Monitor and provide management with impact of changes in the Regulatory environment.
•Plan, coordinate and compile US regulatory submissions with minimal review and with sign-off responsibility.
•Demonstrate strong working knowledge of global laws, regulations, guidelines, standards, and practices related to commercialization and post market surveillance.
•Maintain current knowledge base on existing and emerging regulations, standards, and guidance documents and apply them to change control sign-offs.
•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:
•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.
•B.S. or B.A. degree required.
•A minimum of 5 years of regulatory affairs working experience in the medical device industry.
•A minimum of 1 year of direct supervisory or 2 years mentoring experience.
•Familiarity with U.S. FDA and European/International regulations and standards.
•Extensive knowledge of U.S. FDA or European/International regulations and standards.
•Experience in writing/authoring regulatory or Notified Body submissions (e.g., PMAs, IDEs, 510(k)s, Design Dossiers).
•Experience interacting with FDA, Notified Bodies, and/or other regulatory agencies.
•Demonstrated leadership within a Regulatory Affairs department.
•Demonstrated ability to mentor, coach and train regulatory staff.
•Must demonstrate good technical writing skill.
•Must work will in team environments.
•Must demonstrate good communication skills in a team setting.
•Ability to work in a fast-paced, technically challenging environment where drive is critical to success.
•Effective interpersonal skills/diplomacy and problem solving techniques.
•Proficient on programs within Microsoft Office; Proven analytical abilities, Solid understanding of manufacturing and change control, and an awareness of regulatory trends.
•4 year degree in a technical/scientific discipline.
•8 years of regulatory affairs working experience in the medical device industry.
•3 years of direct supervisory experience.
•Extensive knowledge of U.S. FDA and European/International regulations and standards.
•Regulatory Affairs Certification (RAC).
•Previous experience with ablation, cardiac surgery and Left Atrial Appendage (LAA) closure devices.
•Class III medical device experience.
•General office work environment.
•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