Compliance Specialist

Embla Medical•Nashville, TN

68d•$61,123 - $95,394

About The Position

The Compliance Specialist assists the Director of Compliance with managing the compliance program for Embla Medical’s Americas Business Units. The role manages compliance functions that help ensure the organization follows applicable state and federal regulations, including state insurance laws, federal laws and regulations, and the company’s code of conduct. The specialist supports compliance systems, auditing and monitoring, transparency reporting, training, communications, controls, and stakeholder inquiries. All employees must be aware of and receive general training in Össur Quality requirements during onboarding and New Employee Orientation. More specific Quality training is job-specific, and training related to the quality management system follows the Training Management Process (QM1681). The role also requires appropriate use of company funds and property, professional conduct as a company representative, and attention to workplace safety, including reporting potential hazards.

Requirements

Basic knowledge of risk identification, risk assessment, controls development, training, monitoring, and reporting.
Basic understanding of laws and regulations affecting medical device companies, including anti-kickback, Sunshine Act, False Claims Act, Stark Law, consumer protection laws, FDA regulations, FCPA, and AdvaMed.
Basic understanding of DOJ enforcement actions, corporate compliance guidance, and corporate integrity agreements.
Ability to use discretion and independent judgment when managing and imparting confidential information.
Knowledge of local, state, and federal laws, regulations, and legislation, especially those related to medical device sales.
Strong critical thinking skills and ability to analyze, summarize, and effectively present data.
Strong interpersonal and communication skills and ability to work effectively with a wide range of constituencies.
Demonstrated understanding of compliance systems and controls.

Nice To Haves

Bachelor’s degree in a related field.
2–4 years of relevant work experience in healthcare compliance, preferably in a medical device or pharmaceutical industry setting.

Responsibilities

Support the administration and continuous improvement of the Americas compliance program, including its systems, processes, documentation, and reporting.
Assist with auditing and monitoring across applicable Americas business units; track findings, document results, and support corrective action plans.
Manage compliance systems and platforms, including transparency reporting.
Coordinate compliance training and education, including assignments, completion monitoring, reminders, records, and escalation of overdue assignments.
Help ensure compliance controls operate effectively across relevant business units and collaborate with business leaders as appropriate.
Promote a culture of ethical conduct and commitment to compliance.
Develop policies and programs that encourage managers and employees to report compliance issues.
Recommend and/or implement control enhancements when deficiencies are identified.
Ensure company-wide communication of compliance policies and procedures.
Collaborate in developing, implementing, and monitoring compliance education and training.
Serve as a key contact for stakeholders’ associates on compliance-related questions or concerns.
Explain regulations, policies, and procedures to company personnel and assist product implementation teams in developing related business requirements.
Receive general training in Össur Quality requirements and complete job-specific Quality training as applicable.
Follow the Training Management Process (QM1681) for quality management system training.
Use company funds and property appropriately, maintain an honest and professional attitude, and contribute to a safe workplace by maintaining the workspace and reporting potential hazards.