Compliance Program Manager

The Compliance Program Manager supports the Chief Legal and Compliance Officer (CLCO) of Nihon Kohden North America Inc. (NKNA) in carrying out his/her duties to build and manage an effective Compliance Program for NKNA and all of its U.S. Subsidiaries and to foster a culture of ethics and compliance across the North American organization. Primary responsibilities include implementing and managing all Ethics & Compliance platforms in the Company (e.g. Incident Management System and ThirdParty Due Diligence platform); overseeing the process for Health Care Professional engagement; managing the Grants and Donations Committee process; assisting the CLCO with all seven elements of a Compliance Program; and supporting Employees in following NKNAs Policies and Procedures relating to Ethics & Compliance. At a high level other responsibilities include triaging matters that come to the E&C Department and handling levelappropriate matters; providing substantive and administrative support for all E&C matters; handling routine communications and correspondence; and reporting on E&C matters to internal and external parties as directed.

Essential Functions and Main Duties

• Assists the CLCO in conducting Risk Assessments across the organization including developing circulating analyzing and maintaining Risk Assessment surveys; and ranking/rating relevant risks to NKNA and its Subsidiaries
• Drafts and/or assists the CLCO in drafting E&Crelated Policies and Procedures; maintains E&C Policy & Procedure files for version control; periodically reviews P&P for possible updates
• Creates and/or assists the CLCO in creating various forms of education training and communication on E&C matters including education modules; works with the Learning & Development team to push out education and training to relevant employee populations; maintains an ET&C Program spreadsheet and an Annual Training Plan; drafts edits and/or circulates routine E&C communications to employees
• Manages NKNAs Ethics Helpline (Hotline) pursuant to NKNA Policy & Procedure; serves as System Administrator of NKNAs Incident Management System (IMS) performs quality control on the IMS and generates reports from IMS data; assists the CLCO in confidential investigations as the CLCO may direct
• Assists the CLCO with various Monitoring and Auditing activities related to E&C matters including interaction with other Controls functions in the Company (e.g. Finance HR)
• Implements and manages NKNAs Third Party Due Diligence (TPDD) platform for screening Third Parties who work with NKNA and its Subsidiaries including Distributors Resellers Agents and Suppliers pursuant to NKNA Policy & Procedure; serves as System Administrator of NKNAs TPDD platform performs quality control on the platform manages System workflow renders substantive judgements on Third Parties being screened and generates reports from System data as directed
• Has daytoday responsibility for managing both internal and external requests for Company funding for Health Care Professional or Health Care Organizationrelated events or services including the engagement of HCPs to provide services CompanySponsored Education and Training Exhibiting and Commercial Sponsorships and Clinical Research pursuant to Policy & Procedure
• Manages the Grants and Donations Committee process including triaging of requests preparation of request summaries collection of supporting materials communications and contracting with requesters organization of Committee meetings and maintenance of Committee records of decisions
• In a limited role serves as a backup to the Legal Departments Paralegal for the Companys Contract Management System when the Paralegal is unavailable
• Builds populates and maintains the Ethics & Compliance Departments SharePoint site
• Liaises with various internal business units and third parties in furtherance of his/her duties
• Performs various types of administrative or process administration work (e.g. monitoring mailboxes triaging incoming requests coordinating calendars to set meetings)
• Directly manages or assists with Department initiatives projects and continuous improvement efforts including Compliance Program effectiveness assessments
• Adheres to all company policies procedures and codes
• Adapts to changing duties as NKNA or Department leadership may require based on business need

Qualifications

Education / Certification / Experience Required

• Bachelors degree in science political science business or related discipline
• 5 years of relevant work experience in/with Ethics & Compliance
• Medical device industry experience
• Systems/process administration experience
• Familiarity with/working knowledge of laws regulations and codes relevant to Medical Device industry Ethics & Compliance matters including the AntiKickback Statute the U.S. Foreign Corrupt Practices Act (FCPA) the False Claims Act the Privacy provisions of the Health Insurance Portability and Accountability Act (HIPAA); the Physician Payments Sunshine Act the Food Drug and Cosmetic Act; and the Advanced Medical Technology Association (AdvaMed) Code on Interactions with U.S. Health Care Professionals
• Compliance Certification (e.g. CCEP CHC) preferred
• Health Care Professional (HCP) Interactions experience preferred
• Hotline Management experience preferred
• ThirdParty Due Diligence experience (AntiBribery/AntiCorruption) preferred

Competencies Required

• Ability to think strategically and to formulate creative and practical solutions to business problems in the area of Ethics & Compliance
• Ability to prioritize drive and manage multiple projects and initiatives simultaneously while maintaining E&C processes and platforms on a daytoday basis
• Strong writing editing and presentation skills
• Mature independent judgment and excellent interpersonal skills
• Ability to learn new technology and software platforms; proficiency with one or more Incident Management Systems and ThirdParty Due Diligence systems
• Proficient using Microsoft Office suite (Word Excel Teams Visio PowerPoint SharePoint) and DocuSign
• Must be able to communicate verbally and in writing and to receive and understand verbal and written instructions in English
• Able to work effectively both independently and in a collaborative team environment

Compensation

The anticipated range for this position is $100000 to $125000. Actual placement within the range is dependent on multiple factors including but not limited to skills education experience and location.

Perks and Benefits

Visit our Career page to learn more about Perks & Benefits and working at Nihon Kohden America

Working Conditions

Schedule: The regular hours for this fulltime position are 8:00 a.m. to 5:00 p.m. MondayFriday unless otherwise stated by the Department Manager. Holiday weekend and evening work hours may be required. Regular hours may vary due to the needs of the organization or department and are subject to change at any time at the Companys discretion.

Physical: May require some reaching bending stooping squatting crawling kneeling pushing pulling lifting carrying up to 25 pounds finger dexterity repetitive motions standing walking sitting hearing visual acuity and color vision. More specific details may be provided as needed or requested.

Travel: Minimal

Access to Customer Sites: Not Required

Nihon Kohden America is committed to maintaining a professional and respectful workplace free from discrimination harassment and retaliation and welcomes all qualified candidates to apply. Employment decisions are based on qualifications experience and business needs without regard to legally protected characteristics. This policy applies to all employment actions including recruitment hiring promotion compensation training and other workplace practices.

Nihon Kohden America complies with all applicable federal state and local laws regarding equal employment opportunity. Employees and applicants will not be subject to harassment or retaliation for asserting their legal rights. Questions or concerns regarding this policy may be directed to Human Resources at .