Sr. Manager Healthcare Compliance (Hybrid)

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $5+ billion in sales, 20,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

Senior Manager, Healthcare Compliance, will support the Associate General Counsel – Healthcare Compliance of Terumo Americas Holding and its managed businesses to develop and implement an effective compliance program in accordance with best practices, DOJ most recent guidance, U.S. and O.U.S. ethical industry codes and applicable laws and regulations. Responsibilities will encompass a broad range of areas related to compliance, including the development and implementation of global and regional policies and procedures, training, monitoring and auditing. Senior Compliance Manager will act as the Subject Matter Expert in areas such as: transparency, training, communications, healthcare professional interactions, grants and donations, internal investigations, high-risk third-party vendors management, auditing and monitoring.

Job Details:

• Responsible for managing, coaching and developing a team of compliance professionals in the U.S. and O.U.S.
• Responsible for managing and supporting the implementation of an annual compliance plan and for ensuring that the relevant tasks and initiatives are adopted throughout the organization in the U.S. and O.U.S.
• Develop effective training for high-risk associates and senior leadership. Organize the deployment of training to associates and high risk third parties (distributors).
• Act in partnership with the business and enhance cross-departmental collaborations to develop policies, procedures, guidance, toolkits, that address business needs as they evolve.
• Responsible for developing strong relationships throughout area of responsibility to foster an advisory and collaborative approach to proactive compliance.
• Responsible for supervising and managing a third-party global management program
• Responsible for managing transparency program in the U.S. and European jurisdictions
• Manage the Monitoring Program and continues to develop it to ensure proactive compliance.
• Other duties as assigned.
• Responsible for harmonizing compliance policies and procedures in the U.S. and O.U.S. adhering to multiple jurisdictional legal and compliance standard.
• Maintain and apply working knowledge of current and emerging laws and regulations, and periodically reviews and updates standards relating to compliance. These include Terumo Corporate Policies and Procedures, industry trends and guidance on country, state/provincial or local laws.

Position Requirements:

Knowledge, Skills and Abilities (KSAs)

Excellent analytical, communication and presentation skills with a high-level attention to detail.

Ability to be well-planned, maintain high level of communication and deliver high level quality work.

Able to maintain confidentiality.

Ability to learn quickly, synthesize input from a variety of sources, and think critically and strategically about ethics, risk and compliance.

Able to track progress against identified milestones and report deviations.

Ability to influence without direct authority.

Ability to anticipate impact and proactively take initiative to engage others.

Ability to coach, educate and train others.

Professional demeanor and executive presence.

Strong business acumen and display good judgment.

Background Experiences

Bachelor’s degree and a minimum of 10 years of healthcare / compliance experience in Life Science field required, or equivalent combination of education, training, and experience.

Minimum 3 years management experience required.

Medical device experience preferred.

JD Preferred. Healthcare Compliance Certifications preferred.

Must have an extensive understanding of the AdvaMed Code of Ethics & Medtech Code.

Project management experience a plus.