Director, Ethics & Compliance (Aesthetics and Dermatology)

Role Summary

Director, Ethics & Compliance (Aesthetics and Dermatology) for U.S. operations within Solta Medical and Ortho Dermatologics. Design and implement an effective healthcare compliance program aligned with relevant laws, regulations, and industry codes, under the direction of the Chief Compliance Officer.

Responsibilities

• Provide advice and counsel to Solta Medical and Ortho Dermatologics leadership in the United States by evaluating business strategies and tactics for potential compliance risks.
• Review and pre-authorize transactions where indicated by company policies, including HCP engagements, commercial sponsorships, grant and IIS reviews, and medical device training events.
• Update and maintain polices and procedures in coordination with the US Region Compliance Officer, tailoring them to the risks of each business.
• Assist in the development and rollout of Compliance training and communication to Sales, Marketing, Medical Affairs, and other relevant departments.
• Maintain and enhance processes underlying transparency reporting under the Physician Payments Sunshine Act.
• Support cross-border activities initiated by US personnel, including the Solta Global Strategic Marketing team.
• Execute a comprehensive compliance monitoring program relevant to each business unit, including ride-alongs, observation of speaker programs, advisory boards, sponsorship activities, and third-party due diligence of higher-risk vendors.
• Investigate suspected violations of the Code of Conduct and Compliance policies.
• Evaluate and mitigate data privacy risks pertaining to the collection and use of personal data by Marketing, Clinical, or other company personnel.
• Analyze and review metrics with business unit leaders to raise awareness and remediate gaps in compliance.
• Participate in annual healthcare compliance risk assessments alongside the US Region Compliance Officer and Chief Compliance Officer.
• Maintain regular compliance committee meetings with leaders of the relevant Business Units.

Qualifications

• Eight or more years of U.S. healthcare compliance experience, including experience in the medical device (preferred), diagnostic, or pharmaceutical industries and/or a law degree and four or more years of such experience.
• Subject matter experience with relevant laws and regulations, including:
  • U.S. anticorruption and anti-kickback laws and regulations, including the Federal Antikickback Statute
  • The Physician Payments Sunshine Act
  • Laws and regulations governing medical device and pharmaceutical product promotion
  • The AdvaMed Code of Ethics
  • The PhRMA Code on Interactions with Healthcare Professionals
• Robust communication skills, including experience performing live training in front of large audiences.
• Ability to work effectively with cross-functional teams, multiple levels of management, external advisors, and others.
• Experience performing internal monitoring and conducting misconduct investigations.
• Education: Compliance and/or Legal background with a strong business partnership orientation; law degree or compliance certifications a plus.

Skills

• Healthcare compliance
• Policy development
• Training and communication
• Risk assessment and monitoring
• Data privacy and protection
• Investigation and misconduct handling
• Cross-functional collaboration
• Regulatory knowledge (AKS, Sunshine Act, AdvaMed/PhRMA Codes)

Education

• Compliance and/or Legal background; law degree or compliance certifications a plus.

Additional Requirements

• None specified.