Compliance Specialist

Össur is a leading global provider of innovative mobility solutions that help people live a Life Without Limitations®. Significant ongoing investment in research and development has led to over 2,100 patents, award-winning designs, and successful clinical outcomes. Össur is focused on improving people’s mobility through the delivery of Prosthetics and Bracing & Supports solutions.

About the role

The Compliance Specialist is responsible for assisting the Director of Compliance in the management of the compliance program for Embla Medical’s Americas Business Units. This role ensures the organization follows state and federal regulations including state insurance laws, federal laws and regulations, and the company’s code of conduct.

Responsibilities

• Support the administration and continuous improvement of the Americas compliance program, including compliance systems, processes, documentation, and reporting
• Assist with auditing and monitoring activities across applicable Americas business units, including tracking findings, documenting results, and supporting corrective action plans
• Manage compliance systems and platforms, including transparency reporting
• Help coordinate compliance training and education, including training assignments, completion monitoring, reminders, records, and escalation of overdue assignments
• Ensure that compliance controls operate effectively across the relevant business units and collaborate with business leaders as appropriate
• 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
• Recommend and/or implement control enhancements when control deficiencies are identified
• Ensure company-wide communication of compliance policies and procedures
• Collaborate in the development, implementation, and monitoring of compliance education and training
• Act as a key contact for key stakeholders’ associates for all compliance-related questions or concerns
• Explain regulations, policies, and procedures to company personnel and assist product implementation teams in developing related business requirements
• All employees must be aware of and have received general training in Quality requirements of Össur (training takes place in the Onboarding process and New Employee Orientation; more specific Quality training is job-specific)
• All training related to the quality management system is done in accordance with the Training Management Process (QM1681)
• Exercise good use of company funds and property within set guidelines
• Maintain an honest and professional attitude as the company’s representative at all times
• Contribute to a safe working environment by maintaining own workspace and reporting any potential hazards

Requirements

• Basic knowledge in risk identification, risk assessment, controls development, training, monitoring, and reporting
• Basic understanding of the laws and regulations that impact medical device companies such as anti-kickback, Sunshine Act, False Claims Act, Stark Law, consumer protection laws, FDA, FCPA, and AdvaMed
• Basic understanding of DOJ enforcement actions, corporate compliance guidance, and corporate integrity agreements
• Ability to use discretion and independent judgment to manage and impart confidential information
• Knowledge of local, state, and federal laws, regulations, and legislation, especially related to medical device sales
• 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

Qualifications

• Bachelor’s Degree in a related field
• 2-4 years of relevant working experience in healthcare compliance, preferably in a medical device or pharma industry setting

Benefits

• Medical, Dental, and Vision Benefits
• 401(k) Retirement Plan with employer matching contribution

Pay

The US base pay range for this full-time position is $61,123 - $95,394 + bonus + benefits. Pay ranges are determined by role, level, and location. Individual pay is based on work location and additional factors, including job-related skills, experience, and relevant education or training.