Senior Legal Counsel / Compiance Director

WFH policy - 2 days/week

Overview:

An exceptional opportunity to join a rapidly expanding medical device company and significantly impact the rollout and enhancement of our Legal & Compliance program across the United States, in collaboration with a global team.

Purpose:

The Compliance & Legal Director ensures that our company operates within the framework of all applicable laws and regulations in the medical field, adhering to both professional and internal standards and established business practices. This role is pivotal in leading and managing all regulatory and compliance processes, engaging with internal and external stakeholders, and providing strategic guidance on initiatives and procedures with compliance implications.

Key Responsibilities:

• Policy and Procedure Management: Develop, implement, and maintain policies, training programs, and processes covering areas such as the Anti-Kickback Statute, Sunshine Act, HIPAA, AdvaMed Code of Ethics, Sarbanes-Oxley Act (SOX), harassment, data protection, and conflicts of interest.
• Regulatory Compliance: Continuously evaluate and update materials, policies, and strategies to ensure compliance with relevant regulations and standards. This includes creating and updating training materials for field and non-field staff.
• Strategic Collaboration: Work closely with company leadership to establish, monitor, and assess compliance objectives and milestones.
• Process Alignment: Ensure that key business processes are aligned with regulatory requirements and identify compliance deficiencies, working with management to resolve them using industry best practices.
• Audit and Review: Conduct annual reviews and audits of critical business operations to assess compliance status and compile comprehensive reports reflecting our compliance efforts.
• Incident Management: Lead the compliance investigation process, maintaining a registry of compliance incidents and ensuring proper resolution.
• Legislative Monitoring: Stay informed of legislative developments and implement necessary adjustments within the organization.
• Contractual Review: Draft, review, and negotiate contractual agreements, assessing risks and raising concerns to protect the company's interests.
• Legal Coordination: Coordinate legal proceedings and strategies with external legal counsel and law firms as required.

Skills and Education Requirements:

• Education: Bachelor’s Degree required, preferably in Law or a related field. An advanced legal degree and/or qualification to practice law in the state of Indiana is a plus.
• Experience: A minimum of 8 years of experience in compliance roles within corporate settings or law firms, with at least 5 years in a highly regulated environment, preferably in healthcare or related sectors.
• Legal Knowledge: In-depth understanding of laws, regulations, and standards relevant to the healthcare and medical device industries, particularly those related to sales and marketing, privacy, and anti-corruption.
• Contract Expertise: Proven experience in contract preparation, analysis, and review.
• Communication Skills: Exceptional verbal and written communication abilities.
• Technical Proficiency: Proficiency in Microsoft Office applications, including Word, Excel, and Outlook.
• Certifications: Certification in compliance practices is desirable.

About Leonid Group Corporate Governance:

Leonid Group Corporate Governance is a talent acquisition consultancy specializing in the placement of professionals in Legal, Ethics & Trade Compliance, Data Privacy & Cyber Security, Risk, Audit, and Human Rights & Sustainability roles on an international scale across the Americas, EMEA, and APAC. Our global teams collaborate with multinational corporations to optimize their departments with top-tier professionals, from Global Chief Compliance Officers and General Counsels to Compliance Analysts and Trade Compliance Specialists.