Director of Compliance

Embla Medical•Irvine, CA

About The Position

The Director of Compliance is responsible for leading the compliance strategy and program for the Össur Americas Business Units. This role is responsible for ensuring that Össur Americas has a comprehensive compliance program that ensures that the organization follows state and federal regulations including state and federal laws and regulations. The Director of Compliance is also responsible for signing off compliance risk assessments, communicating the results of such risk assessments to senior management and interfacing with federal and state regulators, if necessary.

Requirements

Law degree or similar background.
5 plus years health care compliance, including 2 plus years managing a compliance program.
Background can be a combination of private practice, government agency practice, and/or in-house position.
Advanced knowledge in risk identification, risk assessment, controls development, training, monitoring, and reporting.
Ability to use independent judgment and to manage and impart confidential information.
Knowledge of local, state, and federal laws, regulations, and legislation, especially related to medical device sales.
Demonstrated ability to develop policies and procedures.
Supervisory, employee development, and leadership skills.
Strong critical thinking skills and the ability to analyze, summarize, and effectively present data.
Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies.
Demonstrated understanding of compliance systems and controls.
Ability to interpret and advise on the application of various laws and regulations including anti-bribery, FCPA, anti-kickback, federal healthcare programs (e.g., Medicare, Medicaid) fraud and abuse, insurance/payor coverage and claims reimbursement.

Responsibilities

Lead, mentor and develop talent within the compliance organization between both corporate and clinic levels
Provide practical, solutions-oriented legal advice, guidance, and representation to the company and its related entities
Oversee compliance with relevant laws, regulations, and corporate policies across various geographic jurisdictions
Lead the ongoing administration of the organization’s compliance program, ensuring day-to-day monitoring and testing activities associated with business operations
Ensure that compliance controls are operating effectively across the relevant business units and collaborate with business leaders as appropriate
Provide strategic compliance guidance and vision to leadership
Promote a culture that encourages ethical conduct and a commitment to compliance
Develop policies and programs that encourage managers and employees to report compliance issues
Set organizational strategy for compliance by staying informed of new product ideas, business strategies and initiatives, merging risks and regulatory changes
Analyze the business impact of regulatory changes
Oversee the ongoing monitoring and testing of the control environment related to the compliance risks identified for the business units and recommend and/or implement control enhancements when control deficiencies are identified
Oversee the development of compliance policies and procedures. Ensure revisions are communicated to relevant associates
Direct and collaborate in the development of multifaceted compliance educational and training programs so that employees and management are knowledgeable of policies and pertinent federal and state legal and regulatory standards.
Act as a key contact to key stakeholders’ associates for all compliance-related questions or concerns
Manage and make reports and recommendations to compliance committee
Explain regulations, policies and procedures to company personnel, and assist the product implementation teams in the development of related business requirements
Support the investigation, tracking, and remediation of confirmed violations of Össur Americas policies and Standards of Conduct; ensure departments timely response to incidents and inquiries received; document the work and actions taken, tracking investigations and inquiries
Perform research, serve as an internal consultant and provide guidance on compliance matters to employees and leadership, coding, physician contracting, fraud & abuse laws, Medicare/Medicaid regulatory requirements or other compliance related subject matter