The Compliance Director is responsible for establishing, leading, and continuously enhancing the company’s compliance framework to ensure full adherence to all applicable laws, regulations, and ethical standards. This role serves as the primary owner of compliance strategy, risk management, and internal controls, ensuring that compliance is embedded across all functions and levels of the organization. The Compliance Director proactively identifies, mitigates, and monitors compliance risks, with a strong focus on healthcare regulations, data privacy, and ethical business conduct. While providing guidance on legal matters when needed, the role is primarily focused on compliance governance, oversight, and enforcement, rather than contract drafting or transactional legal support. External legal counsel will be leveraged for specialized legal matters as appropriate. The Compliance Director also serves as the Associate Data Privacy (ADP) lead, ensuring robust data protection practices and regulatory compliance (e.g., GDPR, HIPAA). Overall goal of the role is to ensure the company operates with the highest standards of compliance, integrity, and accountability while enabling sustainable business growth., Compliance Strategy and Governance

• Develop, implement, and continuously improve the company’s global compliance program
• Establish and maintain a robust compliance framework, including policies, procedures, and controls
• Act as the subject matter expert on compliance-related matters across the organization
• Ensure alignment with healthcare regulatory requirements and ethical standards
• Risk Management and Monitoring
• Identify, assess, and prioritize compliance risks across all business functions
• Design and implement risk mitigation strategies and internal controls
• Conduct regular compliance audits and monitoring activities to detect gaps and vulnerabilities
• Partner with QA and other functions to remediate and prevent non-compliance issues
• Acts as the primary strategist and overseer for the company’s adherence to the Anti-Kickback Statute (AKS) and Stark physician self-referral law. Their chief mandate is to prevent, detect, and remediate any financial arrangement intended to induce or reward referrals for items or services paid for by federal healthcare programs and ensure Stark law compliance

Policies, Training and Culture

• Develop, implement, and update company policies to reflect evolving regulatory requirements
• Drive a strong culture of compliance through communication, education, and training programs
• Ensure employees understand their responsibilities related to compliance and ethical conduct
• Serve as a trusted advisor for compliance-related questions and concerns

Data Privacy and Protection

• Oversee compliance with data protection regulations including GDPR and HIPAA
• Lead and monitor Data Protection Impact Assessments (DPIAs)
• Maintain and oversee the Data Processing Register
• Act as the primary contact for data protection matters and data subject inquiries.

Reporting and Oversight

• Report regularly to leadership on compliance status, risks, and mitigation plans
• Establish KPIs and dashboards to track compliance performance
• Escalate critical compliance issues and ensure timely resolution

Cross-Functional Collaboration

• Partner with QA, Clinical, Commercial, and Operations teams to ensure compliance integration
• Support business initiatives by providing compliance guidance without compromising standards

Do you have experience in Training & development?, Do you have a Bachelor’s degree?, * Bachelor’s degree in Law, Business Administration, Healthcare, or related field; advanced degree preferred, * 10 or more years of experience in healthcare compliance

• Proven experience building and managing compliance programs
• Strong background in compliance audits, risk management, and internal controls
• Deep knowledge of relevant regulations including GDPR, HIPAA, and healthcare compliance
• Excellent English oral and written skills are required.
• Strong leadership and ability to influence without authority
• High integrity and ethical judgment
• Excellent analytical and problem-solving skills
• Ability to translate complex regulations into practical business processes
• Strong communication and training capabilities
• Detail-oriented with a proactive, risk-based mindset
• Ability to operate effectively in a fast-paced, growth-oriented environment, #valueformoney

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Pulled from the full job description

• 401(k)
• Health insurance
• Retirement plan
• 401(k) matching
• Paid time off
• Vision insurance
• Dental insurance, * 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Application Question(s):

• Role involves a heavy amount of manual bench work. Are you open to manual bench work?

SkylineDx is a leading-edge biotechnology company specializing in the development of diagnostic tests for critical conditions such as multiple myeloma and melanoma. Our revolutionary products, Sky92 and Merlin, are transforming the way these diseases are understood, managed, and treated.