Compliance Specialist

Embla Medical•Irvine, CA

6d•Onsite

About The Position

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 is responsible for management of compliance functions that ensure that the organization follows state and federal regulations including state insurance laws, federal laws and regulations, and company’s code of conduct.

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.

Nice To Haves

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

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 to key stakeholders’ associates for all compliance-related questions or concerns
Explain such regulations, policies and procedures to company personnel and assist the product implementation teams in the development of related business requirements
All employees must be aware, have knowledge and shall have received general training in Quality requirements of Össur. Training takes place in the Onboarding process and in New Employee Orientation. More specific Quality training is job specific. All training related to the quality management system is done in accordance to the Training Management Process (QM1681).
Exercises good use of company funds and property within the set guidelines.
Maintains an honest and professional attitude as the company’s representative at all times.
Contributes to a safe working environment by maintaining own workspace and reporting any potential hazards.