Overview

This position is responsible for managing the Compliance Program for Leica Biosystems and Mammotome. Mammotome is a subsidiary of Leica Biosystems manufacturing medical devices in the area of breast biopsy with their headquarters in Cincinnati, Ohio. Both companies are members of Danahers Diagnostic Platform group of companies. The successful candidate will collaborate with the Diagnostics Platform compliance leaders and the business colleagues of Leica Biosystems and Mammotome to develop, implement, and maintain the Compliance Program for the company, to include implementing written policies, procedures, and standards of conduct, leading effective training programs, conducting internal monitoring and auditing, and directing investigations to respond promptly to detected offenses and undertake corrective actions.

The Compliance Director will partner with the Leica Biosystems and Mammotome leadership teams to ensure compliance with industry, regulatory and Danaher Corporation requirements. This position will proactively identify compliance-related gaps or issues and advise the leadership team on how to mitigate potential risks.

The position requires both domestic and international travel, primarily to Leica Biosystems locations in the United States and abroad. A successful candidate will have experience working on or leading a global team. This individual understands the importance of operating with a global mindset and models global and cultural sensitivity.

Major Responsibilities

  • Lead the Compliance Program for Leica Biosystems and Mammotome, to include the following:
    • Responsible for the company’s Compliance Program planning and development functions, ensuring there is a plan designed to meet all Compliance Program requirements, in line with the appropriate legal and regulatory requirements.
    • Lead special project teams of direct and indirect resources in the areas of channel partner management, global transparency reporting obligations, interactions with healthcare professionals and various other areas of compliance.
    • Promote (a) use of the Compliance Hotline, (b) heightened awareness of Standards of Conduct and (c) understanding of new and existing compliance issues and related policies and procedures.
    • Monitor and report results of the compliance/ethics efforts of the Diagnostic Platform and provide guidance for senior leadership on matters relating to compliance.
  • Act as a strategic business partner for senior leadership on matters of major importance to the company and provide information related to all aspects of the Diagnostic Platform’s compliance, including reporting ongoing compliance issues and intentional acts of non-compliance, fraud, waste and abuse.
  • Identify potential areas of compliance vulnerability and risk; develop and implement corrective action plans for resolution of problematic issues and provide general guidance on how to avoid or deal with similar situations in the future.
  • Collaborate closely with colleagues in Legal, Internal Audit, HR, Finance and other core functions in order to direct compliance issues through the appropriate channels for investigation and resolution as well as work towards future improvements as the Compliance Program evolves.
  • Provide an independent review and evaluation body to ensure that compliance issues/concerns within the platform are appropriately evaluated, investigated, and resolved.
  • Monitor, and as necessary, coordinate compliance activities of other departments to remain abreast of the status of all compliance activities and to identify trends.
  • Partner with the appropriate business areas to deliver supplemental compliance training that further amplifies the Danaher corporate program, engages employees and addresses specific needs within Leica Biosystems and Mammotome.

Required Education, Experience, Skills

Education:

  • Bachelor of Science or Bachelor of Arts degree required.
  • Juris Doctor degree a plus.
  • Compliance certifications/credentials preferred.

Required Experience/Skills:

  • 8+ years experience in compliance roles, with increasing levels of responsibility.
  • In-depth knowledge and understanding of applicable regulatory and compliance requirements for healthcare companies, compliance risk management practices and methodologies, including risk assessment, monitoring/surveillance, and testing activities.
  • Knowledge and understanding of legal issues facing global medical device companies including anti-bribery, FCPA, anti-kickback, Medicare fraud and abuse, privacy, Sunshine, etc.
  • Strong project management skills, to include managing and prioritizing multiple concurrent projects, budgeting for the compliance function, and reporting progress and risks to colleagues and senior management.
  • Experience in conducting investigations and managing the entire investigation process, including the management and tracking of the investigation lifecycle and the close-out process.

Preferred Experience:

  • Experience in the medical device industry and the legal and industry regulations/guidelines affecting industry businesses.
  • Experience in developing and maintaining effective lines of communication, including the management of a Compliance Hotline.
  • Experience working on and preferably leading a global team. This individual understands the importance of operating with a global mindset and models global and cultural sensitivity.
  • Experience in the FDA regulatory space, including product promotion and branding experience.
  • Experience in the delivery of effective training

Leadership Skills:

  • Strong project management skills are a priority.
  • Strong relationship management skills: ability to build and partner with leaders of other functional areas within and across the business areas to seek alignment on objectives for the benefit of Leica Biosystems and Danaher Corporation.
  • Ability to apply business and technical expertise to identify potential issues and help solve problems.
  • Strong written and verbal communications skills, ability to act as a change agent through dynamic interactions with others to engender a culture of compliance within Leica Biosystems.
  • Strong negotiation skills.
  • Ability to work in a matrixed, multidisciplinary organization.
  • Experience leading teams to establish direction, motivate colleagues and employees, encourage diverse views, and encourage improvement and development.
  • Ability to set and monitor program objectives that are aligned with global Danaher Corporation objectives as well as the needs of the Leica Biosystems and Mammotome leadership teams and employees.
  • Demonstrated ability to make final decisions regarding the resolution of complex regional or functional business problems, independent of popularity of decision.
  • Professional maturity and confidence in expressing a point of view with senior management.

Travel: Approximately 30% travel Domestic and International. Subject to adjustment dependent on company travel policy post COIVD-19 pandemic.

Language: English

Scope of the Role

Supervisory Responsibility: Responsibility for compliance support of LBS businesses globally; Manager of global compliance team

Approximate Direct Reports:

1

Approximate Indirect Reports:

2

Financial Responsibility

LBS and MMT Wide – $1B

Domestic/International/Global:

International

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.

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