Leica Biosystems Category Legal Job Id R1121665
This job available in 4 locations
Buffalo Grove, Illinois, United States of America
Richmond, Illinois, United States of America
Vista, California, United States of America
Danvers, Massachusetts, United States of America
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
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
Bachelor of Science or Bachelor of Arts degree required.
Compliance certifications/credentials preferred.
8+ years’ experience in compliance roles, with increasing levels
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,
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.
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
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
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.
Ability to work in a matrixed, multidisciplinary
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
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
Scope of the Role
Supervisory Responsibility: Responsibility for compliance
support of LBS businesses globally; Manager of global compliance
Approximate Direct Reports:
Approximate Indirect Reports:
LBS and MMT Wide - $1B
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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