Director / Senior Director, Compliance Officer

Our team is growing, and we currently have an immediate opening for a Director / Senior Director, Compliance Officer Title: Director / Senior Director, Compliance Officer Location: Remote or Hybrid (Cleveland, Ohio) Reports to: Chief Financial Officer Job Description: This position will serve as the compliance lead responsible for all compliance activities, including the Cleveland Diagnostics Compliance Program. The Director / Senior Director, depending on experience, role will serve as the Compliance Officer and will work closely with other cross functional teams including clinical, commercial, marketing, regulatory, quality, and finance to develop, implement, and maintain a comprehensive program that meets all applicable regulatory requirements and industry standards for the promotion and sale of medical services and medical devices. The leader will manage processes and create necessary policies, policy updates, and develop and provide training and materials, transparency and guidance, and work with internal stakeholders to enhance compliance activities based on the legal enforcement environment through applications of best practices. The successful candidate will have specific prior experience in the development and deployment of compliance programs including all seven elements of the OIG recommended program for clinical laboratories, and will have extensive knowledge of federal and state laws (False claims act, Stark Law, EKRA, Antikickback statue) and industry requirements for the diagnostics and medical device laws and experience implementing suitable policies tailored for compliance with these laws. Essential Duties and Responsibilities

• Assume primary responsibility for all compliance policies and educating business stakeholders in their application; Draft, implement, administer and maintain relevant compliance and privacy strategies, policies, procedures, work instructions, and training programs; provide appropriate updates to senior leadership and the Board of Directors
• Collaborate with leadership to promote a culture of compliance, recognizing that compliance is the collective responsibility of all employees, and educate business stakeholders in application of policies and strategically navigating compliance guardrails
• Provide strategic direction across all OIG seven elements of an effective compliance program leveraging knowledge of industry best practices; Manage, provide oversight, and compliance guidance related to engagements with healthcare professionals, as well as engagements related to clinical studies, sponsorships, and pharmaceutical partnerships.
• Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the compliance program, including antikickback and fraud and abuse laws, transparency laws, OIG and DOJ guidelines, and industry standards, such as the AdvaMed and MedTech codes
• Advice on legal issues throughout the medical device lifecycle related to clinical research, market access and reimbursement, product launches, commercialization, advertising and promotion, social media, patient access and financial assistance programs.
• Review promotional and educational materials as part of a cross functional team
• Directly manage compliance related investigations; Ensure reporting to agencies; Timely follow up on incoming inquiries and complaints; Oversee corrective actions as well as remediation plans that address deficiencies in process, procedures, and operational activities
• Advice on all aspects of US and European healthcare privacy laws and regulations, including HIPAA and HITECH, GDPR, and relevant consumer protection laws
• Prepare and validate the federal and state filing compliance reports, such as the US Sunshine Act
• Perform all other duties as assigned Qualifications/Requirements
• Bachelor's degree and 8+ years, or JD or Masters and 6+ years of recent, relevant in-house experience in a compliance or related department of a healthcare organization or law firm experience in a pharmaceutical, biotechnology, or lab industry
• Direct compliance experience in the diagnostics or medical device industry, including at least 3 years related to Class III IVD commercialization and medical device compliance requirements in the US and EU.
• Experience with promotional review committee processes and training cross functional teams
• Proven track record in developing policies and training to drive awareness and deploying risk mitigation strategies; Demonstrated experience presenting to and working directly with company CEO, CFO, sales teams, regulatory teams and management
• In depth knowledge of laws, regulations, and enforcement that affect the medical device or clinical lab industry, including compliance and regulatory elements involving federal (CMS, OIG, FCPA, Federal Anti-Kickback Statute, Stark Law, etc.) and state requirements
• Ability to apply a risk based analysis to compliance issues and demonstrate creativity and flexibility

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