PENTAX Medical · 7 hours ago
Director, Global Compliance
PENTAX Medical is a leader in medical devices focused on improving patient care through innovative endoscopic products and services. The Director, Global Compliance will manage compliance program initiatives for the Americas, ensuring adherence to regulatory requirements and overseeing various compliance projects and training initiatives.
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Responsibilities
Partner with multiple stakeholders throughout the PENTAX Medical organization (legal, HR, operations, internal audit, QA/RA, sales and marketing) with primary focus on the Americas to manage and enhance an effective corporate compliance program and function and ensure that appropriate compliance policies, procedures, and internal controls are in place
Develop, maintain and regularly assess key policies and procedures to mitigate identified risks and meet government and healthcare compliance requirements
Ensure curriculum and training plans align with Business needs and regulatory/legal requirements and that training completion rate remains at 100%
Oversee the global transparency reporting program, ensuring compliance with all applicable spend disclosure and reporting laws and regulations
Understand relevant laws and regulations in key global markets to ensure that PENTAX Medical policies and business practices align with such laws and regulations
Oversee the maintenance of the anti-bribery due diligence screening process for third parties who conduct business with or on behalf of PENTAX Medical
Assist with monitoring and enforcement of compliance efforts, including compliance monitoring activities; risk assessments and reviews of compliance risk areas to determine risk exposure; ongoing collaboration with key stakeholders to identify any issues of non-compliance; and summarize and report same to the Chief Compliance Officer
Conduct and manage compliance investigations regarding allegations of law or company policy or ethical standards and prepare written reports on the findings of such investigations, as directed by the Chief Compliance Officer. Assist with the determination and implementation of corrective actions
Collaborate with the Chief Compliance Officer and global team to continue to enhance the culture of ethics and compliance at PENTAX Medical
Serve as a resource and subject matter expert for all healthcare compliance related activities
Lead on other projects as assigned from time to time
Qualification
Required
Bachelor's degree; Advanced degree or law degree preferred, but not required
10+ years progressive experience
Strong knowledge of key laws and regulations impacting the medical device or life science industry (e.g., AKS, Sunshine Act)
Team oriented, with ability to problem solve and work in a fast paced, ever changing environment
Benefits
Comprehensive benefits program
Generous Paid Time Off and Holiday policy
Company
PENTAX Medical
PENTAX Medical is a division of HOYA Group delivering endo-imaging solutions. It is a sub-organization of Hoya Corporate Venture Capital Group.
Funding
Current Stage
Late StageTotal Funding
$0.12M2019-12-09Grant· $0.12M
2007-10-29Acquired
Recent News
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2025-10-16
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