Job Description

Have you ever felt blown away by the miracles of modern medicine, while also feeling that the patient experience still leaves much to be desired?

Here at Myomo, Inc., it's our mission not only to leverage the power of cutting-edge robotic technology to improve patient quality of life, but also to demonstrate a commitment to prioritize and serve the patient.

We are 1st in the U.S. to develop and market the MyoPro® product line of lightweight, non-invasive, powered arm braces (orthoses) to restore function in the paralyzed or weakened arms and hands of individuals that have suffered a stroke, spinal cord or nerve injury such as brachial plexus injury, or other neuromuscular disability such as traumatic brain injury, (TBI) brachial plexus injury, (BPI) or multiple sclerosis (MS). It is the only device that, sensing a patient’s own neurological signals through non-invasive sensors on the arm, can restore their ability to use their arms and hands so that they can return to work, live independently and reduce their cost of care.

At Myomo, we are driven by a mission to enable independence and confidence for stroke survivors as well as those living with the impact of another neurological disorder. Our teams continue to break through barriers, defining the limits of what is possible in both medical device robotics and our global system of care.

We're currently seeking a strong Director of Compliance to ensure the Company complies with and operates within applicable federal and state healthcare regulations, laws, and internal policies including Medicare (CMS). He/she will support the Company’s Chief Financial Officer (who is Chief Compliance Officer) and will work closely with management to identify potential risks, implement policies and procedures to uphold CMS laws and regulations. The Director of Compliance will also report periodically to the Company’s Audit Committee of the Board of Directors.

Responsibilities

• Assess and manage financial and compliance risks related to HIPAA, CMS, Medicare accreditation, False Claims Act, Anti-Kickback, Stark, OSHA and data privacy, developing strategies to mitigate them.
• Lead the design and/or updating of internal policies and procedures, ensuring adherence to applicable regulations, policies, and laws.
• Deliver regular reports on Compliance topics to management and the Audit Committee.
• Maintain the Company’s Medicare (CMS) accreditation policies, leading re-accreditation efforts.
• Monitor compliance with the Company’s policies and procedures through audit techniques.
• Investigate and report any violations of laws or regulations to management, the Audit Committee and regulatory bodies, as appropriate.
• Actively participate in the Company’s Compliance and Safety Committees.
• Provide guidance to various departments regarding compliance issues and implementation of new compliance requirements with respect to regulatory and contract language.
• Identify, evaluate, and analyze the impact of CMS and Medicare regulatory issues and advise management concerning impact.
• Maintain and track laws and regulations, contract documentations, amendments, and various compliance measures.
• Partner with various departments to ensure that state and/or federal regulatory requirements are communicated and met.
• Assist with the review of product-related social media and television advertising content to ensure CMS compliance prior to broadcast.
• Support review and investigation of CMS compliance incidents including, but not limited to privacy incidents, cybersecurity, policy violations, and potential conflicts of interest.
• Create dashboards and key performance indicator tracking mechanisms that allow for ready access to the detection of actual or suspected non-compliance.
• Help to maintain the Company’s whistleblower hotline.
• Performs other duties as assigned.

Requirements

• Bachelor’s degree in Business Administration, Healthcare Administration, Law or related field/equivalent experience.
• Master's Degree in Business Administration, Healthcare Administration, or related field preferred.
• 7+ years in Compliance, preferably in healthcare environment, required.
• 5+ years with Medicare and/or Managed Care, required.
• Strong knowledge of health plan operations, particularly with government programs (Medicare, Medicaid).
• Deep knowledge of healthcare regulations, policies, and laws impacting a medical device company, including, but not limited to Stark, Medicare fraud and abuse, HIPAA.
• Experience reporting on compliance topics to management and the board of directors.
• Experience with cybersecurity laws and regulations a plus.
• Advanced knowledge of data analysis tools, such as Microsoft Excel.
• Excellent diagnostic and problem-solving skills.
• Excellent communication skills, both written and verbal.
• Outstanding organizational and time-management along with developed interpersonal skills.
• Demonstrated commitment to personal and professional integrity.

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