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 Third-Party 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 NKNA’s 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 level-appropriate 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&C-related 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 NKNA’s Ethics Helpline (Hotline), pursuant to NKNA Policy & Procedure; serves as System Administrator of NKNA’s 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 NKNA’s 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 NKNA’s 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 day-to-day responsibility for managing both internal and external requests for Company funding for Health Care Professional- or Health Care Organization-related events or services, including the engagement of HCPs to provide services, Company-Sponsored 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 back-up to the Legal Department’s Paralegal for the Company’s Contract Management System when the Paralegal is unavailable
• Builds, populates, and maintains the Ethics & Compliance Department’s 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

• Bachelor’s 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 Anti-Kickback 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
• Third-Party Due Diligence experience (Anti-Bribery/Anti-Corruption) 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 day-to-day 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 Third-Party 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 $100,000 to $125,000. 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 full-time position are 8:00 a.m. to 5:00 p.m., Monday–Friday, 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 Company’s 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 HREmployeeServices@nihonkohden.com.