Irvine, CA

Location: Irvine, CA or Remote

Department: Compliance

Reports To: CEO

FLSA Status: Exempt

AIM OF THE POSITION

The primary responsibility is overseeing compliance and ensuring compliance with laws, regulatory requirements, policies, and procedures. As the compliance leader and subject matter expert, this role also includes establishing standards and implementing procedures to ensure the compliance programs throughout the organization are effective and efficient in identifying, preventing, and correcting noncompliance with applicable laws and regulations. Provide reasonable assurance to senior management and the Board that there are effective and efficient policies and procedures in place, well understood and respected by all employees, and that the company is complying with all regulatory requirements. Must be able to provide compliance guidance that balances regulatory requirements, risk mitigation and business objectives.

POSITION WITHIN THE ORGANIZATION

  1. Reports to: Chief Executive Officer (CEO)
  2. Collaborate with: Finance, Medical Affairs, Commercial, Reimbursement, and other core functions.
  3. Participates in:
  • Leadership and Board meetings
  • Department meetings (local)
  • Project meetings
  • Trainings

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Define the necessary level of knowledge on existing and emerging compliance requirements across the organization.
  • Define, develop, and maintain a compliance program including GDRP compliance that aligns with the operations of the company.
  • Implement new policies and procedures for new compliance requirements and support evolving operations.
  • Monitor the effectiveness of the compliance program and mitigate areas of improvement.
  • Provide feedback and trend analysis based on note writing standards; prepare summary audit reports containing findings as well as the methodology used and recommendations for improvement.
  • Manage the billing function for federal, state and other health insurance programs.
  • Onboard, train, and evaluate employees against compliance regulations and program requirements; provide updates and ongoing training on documentation compliance.
  • Onboard, train, and evaluate employees against compliance regulations and program requirements; provide updates and ongoing training on documentation compliance
  • Identify potential areas of compliance vulnerability and risk; develop and implement corrective action plans for resolution of problematic issues and provide general guidance on how to avoid or deal with similar situations in the future.
  • Preparing and presenting clear and concise compliance reports to the Board.
  • Develop policies and programs that encourage managers and employees to report suspected fraud and other improprieties, without fear of retaliation.
  • Independently investigating and acting on matters related to compliance
  • Collaborate closely with Finance, Medical Affairs, Commercial, and other core functions in order to direct compliance issues through the appropriate channels for investigation and resolution as well as work towards future improvements as the Compliance Program evolves.
  • Provide an independent review and evaluation body to ensure that compliance issues/concerns within the platform are appropriately evaluated, investigated, and resolved.
  • Monitor, and as necessary, coordinate compliance activities of other departments to remain abreast of the status of all compliance activities and to identify trends.
  • Proactively plan for emerging trends in compliance, anticipate the impact on processes, and work with business stakeholders to determine how to address them using the most up to date information around emerging state and federal laws, U.S. government enforcement actions, evaluation of Corporate Integrity Agreements, etc.
  • Data Privacy Officer duties and responsibilities.

The above listing represents the general duties considered essential functions of the job and is not to be considered a detailed description of all the work requirements that may be inherent in the position.

EDUCATION AND EXPERIENCE REQUIREMENTS

EDUCATION:

  • Bachelor’s degree required (preferably in a healthcare related field). Master’s degree preferred.
  • Certification in Healthcare Compliance (CHC), Compliance and Ethics (CCEP), or similar is preferred.

EXPERIENCE

  • 10+ years healthcare compliance experience working in a CLIA laboratory/IVD company with a strong auditing background.
  • Experience on the FDA regulatory space to include marketing, branding, etc.

KNOWLEDGE, SKILLS AND ABILITIES (KSA’S)

Specific Knowledge Required:

Knowledge: Comprehension of a body of information acquired by experience or study.

Skill: A present, observable competence to perform a learned activity.

Ability: Competence to perform an observable behavior.

  • In-depth knowledge and understanding of applicable regulatory and compliance requirements for healthcare companies, compliance risk management practices and methodologies, including risk assessment, monitoring/surveillance, and testing activities.
  • Knowledge and understanding of legal issues facing global medical device companies including anti-bribery, FCPA, anti-kickback, Medicare fraud and abuse, privacy, Sunshine, etc.
  • Strong project management skills, to include managing and prioritizing multiple concurrent projects, budgeting for the compliance function, and reporting progress and risks to colleagues and senior management.
  • Experience in conducting investigations and managing the entire investigation process, including the management and tracking of the investigation lifecycle and the close-out process.
  • Strong relationship management skills: ability to build and partner with leaders of other functional areas within and across the business areas to seek alignment on objectives

WORKING ENVIRONMENT

Establishes ADA (Americans with Disabilities Act) requirements

TRAVEL – 15% – 25%

OTHER DUTIES

Other duties as required by management