Description:

Summary:
The Senior Compliance Counsel plays a critical role in supporting Hollister's commitment to legal and ethical conduct and compliance within the highly regulated healthcare industry reporting to the Chief Compliance Officer. While providing comprehensive legal regulatory advice and compliance guidance, ensuring adherence to healthcare laws and regulations. In addition, they will partner and collaborate within Law and with various functions and business units, including Marketing, Sales, Clinical Education, HR, Operations and Quality and Regulatory.

Responsibilities:
  • Strategic Leadership: Drive and continuously enhance the compliance strategy to align with evolving regulations, business objectives, and industry best practices.
  • Regulatory Analysis and Guidance: Monitor, analyze, and interpret federal, state and local healthcare regulations, including but not limited to the U. S. Anti-Kickback Statute, the False Claims Act, Stark Law, U.S. Sunshine Act, and state-specific compliance requirements. Advise internal stakeholders on regulatory changes and impact on business operations. Review contracts, policies and procedures to ensure compliance with applicable U.S. legal and regulatory standards. Act as a subject matter expert and resource for compliance-related questions and concerns.
  • Policy Development and Implementation: Develop, review and update compliance-related policies and procedures to address emerging risks and regulatory changes. Collaborate within Law and cross functionally to implement effective compliance controls and preventative measures. Ensure policies are accessible, understood and consistently applied across the Americas' business units.
  • Audit & Investigation Management: Evaluate allegations of noncompliance in the Americas region and conduct internal investigations of suspected compliance violations. Collaborate with HR and other
  • functions to address violations and recommend corrective actions or disciplinary measures as appropriate.
  • Risk Assessment & Mitigation: Assist in compliance audits and risk assessments for the Americas region to identify vulnerabilities and recommend solutions for improvement.
  • Education & Training: Design and deliver compliance training for all Americas' Associates, promoting awareness, understanding, ownership, and accountability of compliance obligations.
  • Reporting & Metrics: Develop key metrics and prepare regular compliance reports for senior leadership and board of directors on compliance activities, investigations and identified risks.
  • Vendor & Third-Party Oversight: Work closely with business leaders and Compliance team members, be responsible for due diligence, education, and monitoring of the Company's third- party intermediaries to ensure understanding of, and compliance with, Company compliance requirements and applicable laws and regulations.
  • Continuous Improvement: Monitor healthcare industry trends, enforcement actions and best practices to proactively adapt the Company's Compliance Program.

Essential Functions of the Role

  • Communicate effectively via email, phone, and virtual platforms.
  • Collaborate across departments to support organizational goals.
  • Participate in cross-functional meetings and initiatives.
  • Manage multiple priorities and deadlines in a fast-paced environment.
  • Serve as a point of contact for internal and external stakeholders.

Education & Work Requirements

Masters Degree with a minimum of 6 years of related experience

Education & Work Preferences
  • JD from ABA accredited law school required
  • Minimum 8-10 years' legal regulatory experience, preferably in the medical device industry and in the US
  • 3-5 years in-house (preferable with a global healthcare manufacturer)
  • License to practice law and in good standing under the Illinois Bar or the Bar of any state that enables admission to practice as in-house counsel in Illinois is preferred
  • Must be in office 4 days a week

Competencies:
  • Be Agile - Innovates and adapts quickly, approaching change with curiosity while persisting through obstacles.
  • Be Customer Centric Considers the needs experiences and feedback of customers in all we do.
  • Be People-Focused - Builds trust and collaborates with an inclusive and empathetic approach.
  • Be Performance Driven - Operates with an ownership mindset, driving meaningful outcomes.
  • Live The Schneiders' Legacy, Our Noble Purpose - Passionately serves Our Mission and Vision, while demonstrating the Immutable Principles.