Compliance Specialist (Risk Assessment)

At Tactile Medical, we specialize in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency and respiratory illnesses.

The Compliance Specialist is responsible for supporting the development, implementation and execution of the company's corporate compliance and privacy programs. This individual will support the overall functions of the compliance program (auditing, monitoring, training, policy management, investigations, risk assessments) supporting key compliance controls and the business' functional departments with specific support for activities related to privacy.

Accountabilities & Responsibilities

• Assist with ensuring compliance program requirements are fulfilled, including
• Supports completion of quarterly compliance reviews/audits to maintain oversight of various defined risk areas of the company and report on non conformities, adequacy and any recommendations for change
• Supports completion of enterprise and risk assessments, monitoring and auditing functions
• Assists with compliance reporting/analytics and benchmarking
• Assist with external and internal compliance, payer and regulatory audits, reviews, attestations and assessments
• Assist with preparation and updates of training materials, guidance documents, compliance communications and follow up to ensure heightened awareness of the Code of Conduct; and understanding of new and existing compliance issues and related policies and procedures
• Develop/revise and implement company policies, procedures and training to ensure conformance to applicable state and federal health and consumer data privacy statutes and regulations, accreditation standards and other applicable regulatory/legal requirements
• Review/investigate privacy concerns including evaluation of possible breach scenarios and any necessary reporting
• Respond to third party document requests and subpoenas
• Monitor consumer and health data statutes and legislation for relevant updates and or new requirements
• Assist with timely response to inquiries, complaints, cases, and grievances
• Assist with investigating issues and suspected non conformities, reviewing records, tracking progress and and project management, supporting completion of necessary reports, summarizing and documenting issues, answering questions, and participating in other activities of the department.
• Collaborate with and be a liaison to other functional departments such as Reimbursement, Marketing, Sales, Commercial Operations, Payer Relations, Regulatory and Quality to ensure activities are consistent with corporate policy, regulatory and legal requirements
• Conduct research and keep abreast of regulatory changes and developments in the medical device environment, HIPAA and HITECH, breach reporting, and other legal research in support of maintaining an effective program
• Support development of a supportive, inclusive and positive compliance culture
• Other duties as assigned

Education & Experience
Required:

• 3+ years of experience in Legal, Compliance, Risk Management as a paralegal or compliance professional (in healthcare environment preferred)
• Healthcare compliance certification (i.e. CHC, CCEP, CHPC) or other accredited regulatory compliance certification program or willingness to become certified

Preferred:

• Bachelor's degree or Associate's degree

Knowledge & Skills

• Thorough understanding of compliance concepts in the healthcare industry (privacy, fraud and abuse, confidentiality/protected health information, electronic security, anti-kickback, physician/clinician "sunshine" reporting and general regulatory compliance strategies)
• Understanding, training/familiarity with enterprise risk management or compliance risk assessment processes
• Ability to operate in a fast-paced environment with flexibility to prioritize, balance and respond to competing needs within the organization
• Ability to multitask while maintaining strong organizational, analytical and research-oriented skills
• Ability to understand and develop policies, processes and controls
• Excellent oral and written communication skills
• Comfortable working in situations with no clear answer
• Highly effective communicator with the ability to partner cross-functionally to identify and resolve issues
• Familiarity and understanding of:
  • HIPAA/HITECH
  • State privacy statutes (CCPA, CO Privacy Act, etc.)
  • False Claims Act
  • Anti-Kickback statute
  • Sunshine Act/Open Payments Reporting (and separate state statutes)
  • AdvaMed Code of Ethics

Our total compensation package includes medical, dental and vision benefits, retirement benefits, employee stock purchase plan, paid time off, parental leave, family medical leave, volunteer time off and additional leave programs, life insurance, disability coverage, and other life and work wellness benefits and discounts. Benefits may be subject to generally applicable eligibility, waiting period, contributions, and other requirements and conditions.

Below is the starting salary or hourly range for this position, although offers may differ based on the candidate's location, job-specific knowledge, skills and experience.

US Pay Range

$61,500-$86,205 USD

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