Chief Compliance Officer

Location: Cincinnati, OH
Department: Compliance
Employment Duration: Full Time Regular
FLSA Status: Exempt
Job Code: 2019-66
Office based or Remote: Office Based

Description

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:

 

The Company’s Compliance Program is intended to ensure that the Company, and its employees and business partners, are at all times aware of and acting in full compliance with their legal and ethical responsibilities applicable to the commercial activities of medical device companies, including anti-corruption, privacy and medical device promotion. The Chief Compliance Officer (CCO) will lead the company’s global compliance program to ensure business practices and activities of AtriCure and its business partners throughout the world are in compliance with AtriCure internal policies, local laws and regulations, and relevant industry standards. The CCO will serve as a strategic business partner for management and ensure that the company’s culture maintains at its foundation an unwavering commitment to ethics and compliance.

 

The CCO will be responsible for administrative oversight and operation of the Company’s Compliance Program. To promote and support the integrity of the position and optimize the effectiveness of the Compliance Program, the CCO will report to the Senior Vice President & Chief Legal Officer but shall have unrestricted access to the Chief Executive Officer, the Chair of the Compliance, Quality & Risk Committee of the Board, corporate officers and other senior management. Further, the CCO shall have unrestricted access to all Company documents and other business-related information relevant to the performance of his or her duties.

 

ESSENTIAL FUNCTIONS OF THE POSITION:  

This description outlines the major recurring responsibilities of the position and is not intended to be all-inclusive.  Other related job objectives, special assignments and less significant responsibilities will typically be expected of you.

 

Responsibilities:

In carrying out his or her responsibilities, the CCO shall:

  • Direct the day-to-day operations of the Compliance Program throughout the world.

  • Supervise and direct the activities of Compliance Department personnel located at multiple Company facilities around the world.

  • Partner with company leadership to ensure that the compliance program effectively prevents, detects and responds to violations of law, regulations, policies and industry standards.

  • Recruit, hire, train and develop top tier compliance professionals.

  • Communicate pertinent compliance-related information to all areas of the Company in a timely manner.

  • Serve as an advisor to the Board of Directors, senior management and all other employees with respect to compliance-related matters and provide exemplary leadership in promoting the Company’s commitment to compliance and those ethical and compliance values that are reflected in the Compliance Program.

  • Review the content and performance of the Compliance Program on a continuing basis and take appropriate steps to improve its effectiveness.

  • Establish mechanisms and promote an environment where employees and business partners can report compliance related issues via any communication channel available within the Company without fear of retaliation, which includes, but is not limited to, the maintenance of an independent call-in number where employees may anonymously report compliance-related concerns.

  • Review and oversee, either personally or through the coordinated efforts with senior management, the prompt resolution of any alleged violations of the law, rules or regulations, the Code of Conduct or other established Company policies and procedures.

  • Supervise and maintain the integrity of the Ethics hotline such that reports are appropriately logged, investigated, tracked and resolved in a timely manner; calls can be made on an anonymous basis where permitted by law; and the confidentiality of the information is maintained to the maximum extent possible.

  • Develop and maintain documents related to the operation of the Compliance Program including, but not limited to, the Compliance Plan, the Code of Conduct, policies and procedures and educational materials. Coordinate revisions to the Compliance Plan or Code of Conduct, as necessary, in order to respond to the changing needs of the Company and changes in the laws, rules and regulations governing the Company.

  • Coordinate the development and implementation of an effective compliance training program that includes, but is not limited to, training of new employees, addressing specialized training needs and providing periodic training for existing employees.

  • Facilitate the performance of periodic compliance risk-based assessments.

  • Cooperate with the Company’s Senior Director of Risk Management in the implementation of the Company’s compliance monitoring and testing program, by developing an annual testing and monitoring plan, supporting testing and monitoring activities, and ensuring prompt and appropriate actions are taken in response to findings and observations from testing and monitoring activities.

  • Monitor the Company’s procedures related to routine searches of excluded persons maintained by the Department of Health and Human Services’ Office of Inspector General, the Center for Medicare & Medicaid Services, the U.S. Food & Drug Administration, and other government agencies.

  • Maintain a working knowledge of relevant compliance issues, laws and regulations. Assist in the dissemination of information on health care regulatory and legal developments affecting Company operations.

  • Periodically assess Associates’ knowledge of the Code of Conduct and the operations of the Compliance Program and, where appropriate, recommend revisions to the Compliance Program, Compliance Plan and Code of Conduct.

  • Periodically report to the Board of Directors through the appropriate Committee(s) on the status of significant compliance issues and the effectiveness of the Compliance Program.

  • Serve as the Chairperson of the Company’s Compliance Leadership Committee, which shall support the role of the CCO and the effective operation of the Compliance Program.

  • Develop and oversee a global healthcare and privacy compliance monitoring and testing program.

  • Establish and monitor management action plans and guide business partners to timely implement corrective and preventative actions.

  • Be a business partner to the sales and commercial teams, to ensure they have one place to go for compliance and privacy related questions and concerns.

  • Perform such other compliance functions as may be assigned from time to time by the Chief Executive Officer, the Chief Legal Officer or the Board of Directors.

 

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 of Arts or Bachelor of Science required.

  • Minimum of 10 years of health industry experience, with at least five years’ experience in pharmaceutical or medical device compliance management on a global scale.

  • Progressive & proven record of leadership and managing compliance with global responsibility.

  • Absolute commitment to integrity, transparency and professional ethics.

  • Ability to operate with a high degree of sensitivity and confidentiality.

  • Skilled at delegation, follow-up and team-building.

  • Thorough knowledge of healthcare compliance laws, regulations and standards applicable to medical device companies, including those addressing anti-corruption/anti-bribery, privacy and medical device promotion.

  • Excellent communication (verbal and written), organization, interpersonal and presentation skills.

  • Proven track record of both strategic and tactical 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

    • Manage complex, cross functional projects to conclusion

  • Committed team player while taking initiative to get results with minimal supervision.

  • Ability to travel regularly throughout regions of responsibility.

 

PREFERRED QUALIFICATIONS:

  • CCEP and/or CCEP-I certification.

  • Prior experience as Chief Compliance Officer for a public medical device, biotech or pharmaceutical company.

 

OTHER REQUIREMENTS:

  • Able to regularly walk, sit, or stand as required.

  • Able to occasionally bend and push/pull.

  • Able to regularly lift up to 25 pounds.

  • Able to pass pre-employment drug screen and background check.

  • Able to travel up to 25% of the time, including internationally.

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




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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