Compliance Officer

Our team is growing, and we currently have an immediate opening for a Compliance Officer

Title: Compliance Officer

Location: Remote or Hybrid (Cleveland, Ohio)

Reports to: Chief Financial Officer

Job Description: This new position will serve as the organization’s head of compliance and lead responsible for all compliance activities, including the Cleveland Diagnostics Compliance Program. The Compliance Officer will be considered the subject matter expert and will need to 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 Compliance Officer 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

• Lead, manage, and have primary responsibility over compliance programs, policies, and awareness and provide guidance related to engagements with healthcare professionals globally
• 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
  
  
  

Qualifications/Requirements

• Bachelor’s degree and 7+ years, or JD or Masters and 5+ 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
• 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 in developing solutions to novel issues to prevent and mitigate risks that satisfy both business requirements and legal obligations
• Ability to work independently, change priorities, learn new topics and processes, and take on varied assignments in a fast-paced environment and to handle multiple complex and confidential tasks
• Ability to manage and assist in the implementation of technical solutions to manage the HCP engagement processes
• Excellent oral and written communication skills, with the ability to distill complex legal considerations into practical actionable advice
• Knowledge of and experience with privacy laws and global trade compliance laws (GDPR, HIPAA, APPI and others), preferred
• Certifications in Healthcare Fraud & Abuse Law Compliance, or similar, preferred
• Experience drafting, reviewing, and negotiating commercial arrangements, including HR agreements, laboratory service agreements, phlebotomy service agreements, clinical trial agreements, and professional services agreements with health care providers, preferred
• Prior experience working with or engaging with relevant government agencies, preferred
  
  
  

Physical Requirements/ Working Conditions/Equipment Used:

• Work involves a fast-paced laboratory/office environment with a substantial amount of sitting and operating a computer and/or phone. Offices reachable by elevator but should be able to climb stairs in case elevator out.
  
  
  

Cleveland Diagnostics, Inc., is developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. Its portfolio of non-invasive diagnostics will be expanding from prostate cancer to breast cancer and lung cancer. We pride ourselves in fostering a family-focused, friendly, and flexible organization that places our employee’s well-being and happiness as the primary reason for our success. Are you interested in building your career with a team of industry professionals while making a lasting impact to the lives of millions of people? Bring your talents to Cleveland Diagnostics.

Cleveland Diagnostics offers an extremely robust benefits package which includes:

• 100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage
• 100% Employer-paid Dental & Vision for entire family
• No cost for employee coverage for Group Term Life, Short- & Long-Term Disability
• 4% retirement contribution Employer match
• Incentive Performance Plan & Stock Option Program & Commission (Sales Account Execs)
• Paid Family Leave Program
• Generous PTO plan & holiday program
• Flexible work schedule & lucrative employee referral program
• Salary range may vary by work state/geographical region/territory
• Easy to get to office location with newly built-out office space
• Free coffee, snacks and other goodies all day long
  
  
  

Cleveland Diagnostics is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination. We celebrate the unique differences of our employees because that is what drives curiosity, innovation, and the success of our business. EEO is the Law. Applicants can learn more about the company’s status as an equal opportunity employer by viewing the federal EEO is the Law poster on our careers page. Accommodations are available for applicants with disabilities.