Director, Global Compliance

Director, Global Compliance

Our mission is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic products and services with a focus on quality, clinically relevant innovation, and simplicity. Through leading edge R&D and manufacturing, PENTAX Medical provides endoscopic imaging devices and solutions to the global medical community.

This role will be a member of the Global Compliance team, providing day-to-day management of compliance program initiatives, primarily for the Americas. This role will provide support and guidance to the Americas Sales and Marketing teams serving as Compliance Business Partner. This role will have direct or indirect responsibility for managing specific compliance programs and projects, including Pentax Medical's Spend Transparency; Grants and Donations; engagement of healthcare professionals; new and existing compliance policies and SOPs; compliance communication and awareness materials; employee training; global risk management and compliance investigations as directed by the Chief Compliance Officer. Will have direct responsibility for direct report(s).

Responsibilities of Director, Global Compliance :

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.

Requirements of Director, Global Compliance :

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.

It is the ongoing policy and practice of PENTAX Medical to provide equal opportunity in employment to all employees and applicants. No person shall be discriminated against in any condition of employment because of age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law.