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Manager, Legal Compliance and Ethics

Posted Feb 01
Full Time
RemoteCalifornia

About Us:

Cue Health (Nasdaq: HLTH) is a mission-driven healthcare technology company that puts consumers in control of their health information and places diagnostic information at the center of care. Cue Health enables people to manage their health through real-time, actionable, and connected health information, offering individuals and their healthcare providers easy access to lab-quality diagnostics anywhere, anytime, in a device that fits in the palm of the hand. Cue Health’s first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without physician supervision. Outside the United States, Cue Health has received the CE mark in the European Union, Interim Order authorization from Health Canada, and regulatory approval from India’s Central Drugs Standard Control Organisation. Cue Health was founded in 2010 and is headquartered in San Diego. For more information, please visit www.cuehealth.com

Cue Health Inc. is seeking to hire full-time Manager, Legal Compliance and Ethics.  The Manager, Legal Compliance and Ethics will provide centralized direction and oversight of the Company’s ethics and compliance efforts, including the administration, investigation, and enforcement of the Company’s ethics, compliance plan and policies, reporting to the Company’s General Counsel and/or Compliance Officer.  The individual in this role will ensure the Company’s Compliance Program aligns to federal guidelines for an effective program, and then work to foster a culture of ethical and compliant behavior from all employees throughout the Company. Provides leadership and guidance to assigned staff.

 

Responsibilities:

  • In consultation with the Compliance Officer, oversee, coordinate and monitor the day-to-day compliance activities of the Company

  • Maintain and supplement the Company’s Code of Business Conduct and Ethics, as needed, but at least annually

  • Develop compliance training specifically related to applicable healthcare regulations

  • Work with various departments to coordinate and conduct compliance training for all employees on all applicable compliance-related topics (fraud, waste, and abuse, Anti-Kickback, Stark, Sunshine Act, FDA, FTC, anti-trust, insider trading, employment, etc.)

  • In consultation with the Compliance Officer, audit and assess the Company compliance program effectiveness, training and adherence within the company

  • Responsible for training to ensure compliance to the Sunshine Law and reporting of applicable payments into the Open Payments system via the CMS Enterprise Portal

  • Ensure employees understand the Company’s commitment to comply with all applicable laws, regulations, company policies, and Code of Business Conduct and Ethics

  • Oversee internal and external audit procedures for the purpose of monitoring and detecting any misconduct or noncompliance. Report any misconduct or noncompliance to the Compliance Officer, recommend a solution, and follow up to ensure mutually agreed upon solution has been implemented

  • Ensure the Company’s anonymous reporting system is adequately publicized and that allegations of noncompliance are investigated and responded to promptly

  • Track all issues referred to the Compliance Officer or compliance reporting system

  • Coordinate with the Compliance Officer in investigations of matters that merit investigation under the Code of Business Conduct and Ethics

  • In consultation with the Compliance Officer and Human Resources, help ensure the existence of mechanisms for disciplining instances of noncompliance (including failure to prevent, detect, or report any noncompliance), appropriate to the nature and extent of the deviation and ensure consistency in application of disciplinary actions

  • Work with Human Resources, Purchasing, or the appropriate internal parties to audit background, excluded provider, and reference checks for all potential employees, consultants, directors, and vendors. Oversee the excluded provider checks of all vendors

  • Develop periodic and annual reports on the compliance program to be shared with Board of Directors, including an annual review and updates to the compliance program and compliance plan

  • In conjunction with the Compliance Officer, interface as appropriate with external US and international regulatory agencies

  • Conduct regularly scheduled Compliance Committee meetings, or as otherwise necessary, meet with committee on any significant compliance issues to ensure appropriate company response and action is implemented

  • Develop productive working relationship employees within all levels and departments

  • Provide oversight, direction, training, and coaching to assigned staff

  • Additional duties as assigned

 

Requirements:

  • Typically requires in a bachelor’s degree in a related field or equivalent

  • 8+ years’ relevant work experience including experience in a CMS, FDA, and/or ISO-regulated environment

  • 1+ years of personnel management or leadership experience

  • Direct experience with FDA and/or CMS regulations

  • Knowledge of industry standards and the nuances related to US and international regulatory and compliance documentation

  • Knowledge of Sunshine Law and reporting to the Open Payments system via the CMS Enterprise Portal

  • Exceptional written and verbal communication skills

  • High quality, professional interpersonal skills

  • Collaboration skills and the ability to partner with and influence cross-functional personnel

  • The flexibility to change approaches in differing situation and respond seamlessly to new priorities and assignments

  • Experience working with and advising internal clients directly

  • Experience providing guidance and practical solutions

  • Analytical ability and strong attention to detail

  • Excellent business judgment

  • Self-motivation and drive, with a passion for teamwork

  • Ability to apply a high level of discretion, common sense and good judgment to ambiguous situations

 

Environment and Physical Activities/Requirements:

  • You will work in an indoor remote environment for which no adverse conditions are expected.  This position requires the following physical activities and/or requirements:

      • Remaining in a stationary or sedentary position, often standing and/or sitting for prolonged periods of time

      • Repeating motions, such as keyboarding, that may include the wrists, hands, and/or fingers

      • Communicating with others to exchange information

      • Adjusting, moving, carrying, lifting, pushing or pulling objects up to 20 pounds

 

Your contribution will set the pace and have an impact in the technology, health, and diagnostic industry. Your work and ideas will be valued and respected, and we hope you will find enjoyment working with a collaborative team on an innovative device. We offer upgraded computer equipment, unlimited snacks, and a competitive salary.

 

Cue Health Inc. is an equal opportunity employer, consistent with applicable laws. Individuals seeking employment are considered without regards to race, color, religion (including religious accommodations), creed, sex (including pregnancy, childbirth and related medical conditions), gender (including gender identity and expression), sexual orientation, marital status, national origin (including language use restrictions), ancestry, mental and/or physical disability, medical condition (cancer, genetic information and characteristics, requests for medical and family care leave), age, military or veteran status, and any other classification protected by applicable federal, state, and local laws.

The estimated base compensation range for this role is shown below. This range is based upon current market data and other factors, all of which are subject to change. Individual pay will be determined in accordance with a candidate's location, skills, expertise, background, experience, and other relevant factors. Applicants are always welcome to direct questions regarding this range to the Talent Acquisition specialist recruiting for this position.

 

Base Compensation Range:

$93,000.00 - $155,000.00

Pay Rate:

Salary

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