Director, Ethics & Compliance (Aesthetics and Dermatology)

Role Summary

Director, Ethics & Compliance (Aesthetics and Dermatology) for U.S. operations, partnering with Solta Medical and Ortho Dermatologics to design and implement an effective healthcare compliance program in alignment with applicable laws, regulations, and industry codes.

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 policies, including HCP engagements, commercial sponsorships, grant and IIS reviews, and medical device training events.
• Update and maintain policies and procedures, tailored to the risks of each business, in coordination with the US Region Compliance Officer.
• 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 in collaboration with the privacy officer.
• Analyze and review metrics with business unit leaders to raise awareness and remediate gaps in compliance.
• Participate in annual healthcare compliance risk assessments with 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 in the medical device, diagnostic, or pharmaceutical industries; or a law degree with four+ years of such experience.
• Subject matter expertise in relevant laws and regulations, including:
  • U.S. anticorruption and anti-kickback laws (Federal Anti-Kickback Statute)
  • Physician Payments Sunshine Act
  • Promotional laws and regulations for medical devices and pharmaceuticals
  • AdvaMed Code of Ethics
  • PhRMA Code on Interactions with Healthcare Professionals
• Strong communication skills, including experience delivering live trainings to large audiences.
• Ability to work effectively with cross-functional teams, multiple management levels, external advisors, and others.
• Experience performing internal monitoring and misconduct investigations.
• Education: Compliance and/or Legal background with a strong business partnership orientation; law degree or compliance certifications a plus.

Skills

• Policy development and implementation
• Training and communications
• Risk assessment and monitoring
• Investigations and due diligence
• Data privacy risk management
• Cross-functional collaboration

Education

• Law degree or compliance certifications a plus

Additional Requirements

• Travel expectations are not specified in the source.