Treace’s mission is to be the leader in the surgical treatment of bunions by establishing the Lapiplasty® System as the standard of care. We are committed to operating our business with the highest standards of ethical conduct. We intend to exceed our customers’ expectations through an innovation-driven, high-velocity approach to solving treatment and surgical problems. With our products and services, our mission is to assist foot and ankle surgeons in improving patient outcomes and reducing healthcare costs, while providing rewarding experiences and opportunities for our employees and stakeholders.

As the Sr. Compliance Manager, you will oversee legal and compliance matters, both independently and in collaboration with the Legal and Compliance teams to ensure that the company operates in compliance with Treace Policies and applicable healthcare laws.

What you will be responsible for:

Legal:

• Responsible for the day-to-day management of Treace Medical’s contract lifecycle management activities to ensure efficient processes, templates, and technology to enable business operations.
• Lead the development of materials for business counterparts such as playbooks, work instructions, and frequently asked questions with repeatable legal advice in partnership with Legal team.
• Draft/review contract policies and procedures, assess process and technology. Support the development of new or updated processes or technology improvements to improve operations.
• Manage/draft/review/negotiate complex legal contracts to ensure compliance with laws and regulations in the healthcare landscape and Treace healthcare legal and compliance policies.
• Work with members of the legal team to drive progress on cross-functional projects while looking for opportunities to improve processes to help the company scale
• Liaises internally across departments and externally to mitigate legal risks and to provide guidance to employees/customers on complex legal questions or concerns.

Compliance:

• Responsible for the day-to-day management of Treace Medical healthcare compliance activities to ensure compliance with (i) laws and regulations in the healthcare landscape; (ii) Treace healthcare policies.
• Develops and updates healthcare compliance policies and procedures. Conduct healthcare compliance policy and procedure assessment.  Support development of new or updated policies to address new risk areas or to improve operations and/or internal controls.
• Conduct healthcare compliance risk analysis.  Identify potential areas of compliance vulnerability and risk.  Develop and implement action plans to mitigate potential risks.
• Manage healthcare compliance training program on the Treace healthcare policies as well as:
  • Oversee compliance training in other laws including the Physician Payment Sunshine Act, the Federal Food, Drug and Cosmetic Act, HIPAA and similar state laws to educate employees on legal and ethical standards and to ensure a comprehensive understanding.
• Leverage understanding and familiarity with OIG-DHHS seven elements of an effective compliance program, and the AdvaMed Code.
• Execute internal auditing and monitoring for policy compliance.  Track corrective and preventive action plans associated with previous audit findings.  Manage internal and external corrective action plans.
• Keep abreast of new legislation and enforcement matters affecting global companies as well as healthcare industry and compliance best practices.
• Collaborate closely with colleagues in Legal, IT, HR, Finance, Regulatory and other core functions in order to direct compliance issues through the appropriate channels for investigation and resolution, reporting and remediation.
• Prepare management reports to Treace Management on incidents, investigations, emerging compliance challenges and general compliance activities.  
• Conduct pre-acquisition due diligence of new healthcare businesses and develop/implement integration plan.
• Support in the execution of HIPAA privacy responsibilities.

• Bachelor’s Degree required in finance, business administration, legal studies, or related field.
• Minimum 6-8 years of relevant healthcare compliance or legal experience, with preferred experience in the medical device, healthcare, or pharmaceutical industry
• Additional certification in Ethics and Compliance is preferred.
• Effective oral and written communication skills.
• Ability to analyze and interpret complex governmental regulations.

All your information will be kept confidential according to EEO guidelines.

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Treace is a drug free employer.