Regulatory Affairs Specialist

7 days ago

Minneapolis Minnesota, United States Tactile Medical Full time
Job Summary

Tactile Medical is seeking a highly skilled Compliance Program Manager to join our team. As a key member of our compliance department, you will be responsible for assisting in the ongoing progression and maintenance of our corporate compliance and accreditation program.

Key Responsibilities
  • Develop and enhance compliance training programs, including training communications and follow-up.
  • Assist with conducting investigations, resolving, and documenting compliance issues and questions, including suspected nonconformities to our compliance program requirements.
  • Conduct risk assessments, document outcomes, and implement follow-up actions.
  • Coordinate with various departments to ensure annual Sunshine Act reporting (Federal and state requirements) is accurately completed and follow-up activities are implemented as needed.
  • Communicate with various stakeholders to ensure activities are consistent with regulatory and legal requirements.
  • Assist with ensuring compliance program requirements are fulfilled, including supporting the elements of program reviews.
  • Ensure ongoing, monthly exclusion reviews are completed as required and resolve issues as they arise.
  • Assist with external and internal compliance and regulatory audits.
  • Support the development of an inclusive, collaborative, and positive compliance culture.
Qualifications
  • Bachelor's Degree or an equivalent combination of education and work experience.
  • 4+ years of compliance expertise.
  • Previous medical device or medical provider experience is preferred.
  • Certification as CHC, CHPC, or willingness to become certified.
  • Previous experience supporting compliance initiatives within a large organization.
Requirements
  • Strong proficiency with Microsoft Office tools, including Word, Excel, PowerPoint, and Teams.
  • Ability to establish credibility and build strong collaborative relationships with various stakeholders.
  • Ability to design and/or enhance effective compliance training programs for the adult learner.
  • Strong written and verbal communication skills and demonstrated ability to effectively communicate with a wide-ranging audience.
  • Strong organizational skills and efficiently manages tasks and responsibilities.
  • Proficiency in understanding of compliance concepts in the healthcare industry, including confidentiality/protected health information, electronic security, False Claims Act, Anti-Kickback statute, HIPAA, Sunshine Act/Open Payments Reporting, and AdvaMed Code of Ethics.

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