Compliance Manager

ABIOMED

Danvers, MA

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Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, and offices in Baltimore, MD, Woburn, MA, Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 2,000 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.

Patients First | Innovation | Winning Culture | Heart Recovery

The Compliance Manager contributes to the departmental strategy and key strategic imperatives, optimizing the tactics for continuously evolving and improving Abiomed’s Compliance program. Responsibilities will encompass a broad range of areas related to compliance, including the development and implementation of global and regional policies and procedures, training, monitoring and auditing. The Compliance Manager will assist in areas such as: transparency, training, communications, healthcare professional interactions, grants and donations, internal investigations, high-risk third-party vendors management, auditing and monitoring. In addition, they successfully partner with cross-functional stakeholders to compliantly and ethically execute on the organization's goals, objectives, mission, vision and values.

The responsibilities of the position include, but are not limited to, the following:

  • Identifying Compliance risk areas and developing strategies to address risk areas
  • Leading the creation, deployment and assignment of e-learning modules
  • Assisting in the investigation of alleged breaches of laws, regulations and policies and performing corrective actions
  • Coordinating compliance tracking and monitoring activities and supporting the efforts of the Corporate Compliance Committee
  • Assisting with and supporting the development of the annual Compliance auditing and monitoring plans
  • Develop approaches for monitoring using data from various financial and business systems (e.g., SAP, Concur) and using data mining techniques to assist with monitoring
  • Providing relevant guidance and insight into policy development; and identifying program enhancements to address Compliance risk areas
  • Supporting the Chief Compliance Officer on Corporate level initiatives, as needed
  • Ensuring conformance with Compliance related matters in M&A projects from the due diligence phase to final integration
  • Developing and implementing the compliance communication strategy to foster a values-based culture
  • Adhering to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies

REQUIREMENTS:

  • Bachelor's degree combined with 1 to 3 years of healthcare compliance experience with a medical device or pharmaceutical company. JD or Masters, preferred
  • HCCA or Seton Hall Healthcare Compliance preferred
  • Demonstrated knowledge of legal, regulatory and political environments in the compliance areas
  • High degree of integrity, discretion, self-motivation and initiative
  • Able to work independently and handle a wide variety of situations, including conflict resolution and troubleshooting issues.
  • Proficiency in Microsoft Office (Word, PowerPoint, Excel, and Outlook) is required.
  • Excellent verbal/written communication, organizational, prioritization, time-management skills and attention to detail required.

Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.