Director, Healthcare Compliance

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 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 Director, Healthcare Compliance, will serve as a Healthcare and Privacy Compliance Director for AtriCure throughout the United States. In this role, you will lead the healthcare and privacy compliance program to ensure business practices and activities of AtriCure and its business partners throughout the US are in compliance with AtriCure internal policies, local laws and regulations, and relevant industry standards. You will serve as a strategic business partner for management and coaching towards all employees, to assure that the company culture of compliance is a natural element in day-to-day business. Position is located in Mason, OH.

 

 

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.

 

Your main responsibility will be to partner with company executive leadership to ensure that the compliance program effectively prevents, detects and responds to violations of law, regulations, policies and industry standards in the US by:

 

  • Monitoring developments and changes in best practices and regional regulatory and legislative requirements to advise the wider organization on necessary organizational changes.
  • Interfacing with legal counsel regarding healthcare and privacy compliance requirements and interpretation
  •  
  • Assisting in drafting, reviewing, revising, and implementing compliance policies and procedures for the US,
  • Stimulating and contributing to innovative approaches towards interactions with healthcare professionals and government officials in a manner consistent with AtriCure corporate guidelines and policies
  • Working closely with the AtriCure corporate office and third parties to shape and influence the business environment and industry codes of conduct
  • Providing and coordinating appropriate guidance, education, training, and regular communications on healthcare and privacy compliance to all covered employees
  • Conducting self-assessments and risk assessments to detect process deficiencies, and make recommendations for addressing the identified deficiencies
  • In conjunction with other compliance department personnel, Developing and overseeing a healthcare and privacy compliance monitoring and testing program for the US
  • Monitoring outstanding management action plans for the US and guiding business partners to correct gaps with timely implementation of corrective actions
  • Conducting investigations of non-compliance and escalated allegations, as appropriate, and documenting outcomes
  • 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. 
  • Help to create compliance strategy based on company priorities, national and international laws/regulations and risk management priorities.  Drive and manage projects assigned as a result of the strategy.
  • Other duties as assigned by the Chief Compliance Officer

 

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
  • Minimum of 10 years of health industry experience, with at least five years’ experience in pharmaceutical or medical device compliance management
  • Absolute commitment to integrity and professional ethics
  • 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
  • Strong organizational, interpersonal, analytical and communication 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 region of responsibility

 

PREFERRED QUALIFICATIONS:

  • CCEP and/or CCEP-I certification
  • Prior experience as Compliance Officer for a business unit or operational region of public 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
  • Up to 25% travel may be required

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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