AtriCure

Compensation

Full Description

AtriCure, Inc. provides innovative technologies for the treatment of 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 medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure’s Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure’s cryoICE cryoSPHERE® probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure. We foster a culture of inclusion by embracing diverse experiences and individuals where everyone’s authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally. POSITION SUMMARY: We are seeking a Senior Compliance Manager, Americas to manage and execute the compliance program across the Americas region (North, Central, and South America). This individual will ensure adherence to applicable healthcare, anti-corruption, regulatory, and data privacy laws. The role requires strong compliance and risk management skills, and the ability to partner cross-functionally with commercial, legal, regulatory, and operational teams. This is an individual contributor role with the opportunity for growth. ESSENTIAL FUNCTIONS OF THE POSITION: • Manage the implementation and execution of the regional compliance strategy in alignment with global corporate policies and regulatory requirements • Provide subject matter expertise and guidance on healthcare compliance (including Anti-Kickback Statute, False Claims Act, FCPA, AdvaMed Code, and local equivalents in LATAM and Canada • Support and execute the risk assessment and mitigation process for the Americas, helping to identify and address emerging compliance risks in the Americas region. • Involvement with the third-party due diligence process, including distributors, consultants, and vendors. • Partner with legal, and HR teams to investigate and remediate compliance incidents. • Support monitoring and auditing programs and remediate identified issues. • Collaborate with commercial leaders to ensure compliant business practices, particularly around interactions with healthcare professionals (HCPs) and referral sources. • Review HCP engagement needs assessments, participate in research grants and educational grants review committees • Participate in global compliance meetings and projects, providing regional input and helping to execute company-wide compliance initiatives. • Keep abreast of regulatory changes and enforcement trends affecting the medical device industry. • Assist in drafting, reviewing, revising, and implementing compliance policies and procedures globally • Manage the execution of the training and communication plan, providing recommendations as appropriate • Participate in conducting risk assessments to detect process deficiencies, and revise and recommend changes to the Work Plan to address the identified deficiencies • Provide input on annual risk assessments and recommend changes to the Annual Work Plan accordingly • Other duties as assigned by the Chief Legal Officer ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION: • Regular and predictable worksite attendance or remote work as agreed to with the Chief Legal Officer • Ability to make decisions and use good judgement • Ability to prioritize various duties and multitask as required • Ability to successfully work with others and contribute to overall team performance • Additional duties as assigned BASIC QUALIFICATIONS: • Bachelor of Arts or Bachelor of Science • Minimum of seven years of healthcare industry experience, with at least three years’ experience in pharmaceutical or medical device compliance or quality management • Absolute commitment to integrity and professional ethics • Understanding of laws and industry standards governing medical device company interactions with healthcare professionals • Strong organizational, interpersonal, analytical and communication skills • Strong track record of tactical execution and operational management capabilities, demonstrating the ability to: • * Innovate and execute in a complex business environment • Foster relationships and influence business decisions and business partners, both throughout the company and external parties • Combine regional orientation with global goals and objectives • Manage complex, cross functional or global projects to conclusion • Committed team player while taking initiative to get results with minimal supervision • Ability to travel regionally (up to 50%) PREFERRED QUALIFICATIONS: • Prior experience as Compliance Officer for a business unit or operational region of a medical device, biotech or pharmaceutical company OTHER REQUIREMENTS: • Ability to regularly walk, sit, or stand as required • Ability to occasionally bend and push/pull • Ability to regularly lift up to 25 pounds, occasionally lift up to 25 pounds • Ability to pass pre-employment drug screen and background check 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, 20 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/careers-atricure/benefits. 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 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).