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Terumo Blood and Cell Technologies · 1 day ago

Associate General Counsel and Deputy Chief Compliance Officer (Remote)

United States

Full-time

Remote

Director/Executive

$237K/yr - $296K/yr

15+ years exp

Terumo Blood and Cell Technologies is seeking an Associate General Counsel and Deputy Chief Compliance Officer to foster a culture of ethics and compliance across the organization. The role involves developing and maintaining a global compliance program, ensuring adherence to laws and regulations, and leading a team of compliance professionals to manage risks and support various business functions.

Medical Device

Hiring Manager

Connor Bemiller

Responsibilities

Partner with the Chief Compliance Officer and senior leadership to maintain and further develop a strong compliance culture, including personal accountability at all levels in the organization. Develop a global risk-based compliance strategy aligned with business strategic goals, industry regulations and emerging risks. Implementing measures to prevent, detect and correct illegal, unethical, or improper conduct

Develop and execute global Compliance Action Plans

Provide strategic advisory on compliance matters and pursue commercial excellence when partnering with corporate functions and commercial divisions

Adopt technology to automate and scale processes based on global and regional needs

Oversee strategic projects and daily operations, ensuring that organizational design support the compliance strategy and business needs

Develop compliance talent

Coordinate external compliance resources

Chairs Global Compliance Committee and supports regional compliance meetings

Conduct periodic compliance risk assessments and audits

Implement risk mitigation strategies

Support Cross-Functional Risk Management

Assist with cybersecurity efforts

Contribute to data privacy initiatives

Participate in enterprise risk management

Establish, implement, and oversee global compliance-related policies and procedures

Collaborate closely with legal and compliance associates

Focus on health care compliance, data privacy compliance, regulatory compliance, and other related matters

Ensure policies align with international regulations and group company standards

Manage and maintain the company-wide complaint system

Ensure all complaints are addressed promptly and effectively

Conduct root cause analysis for repeated complaints

Oversee high level investigations and respond to violation of policies, regulations, laws, and standards of conduct through the initiation of

Prepare and deliver regular reports to Terumo Corporation and EMC on complaint status and resolutions

Provide expert guidance on compliance matters to various business units and functional areas

Support Commercial Excellence, Regulatory, Clinical, Sales, and other departments as needed

Collaborate with regional compliance advisors to ensure consistent global compliance practices

Coordinate and oversee all medical device compliance-related activities on a global scale

Stay updated on international medical device regulations and ensure company-wide adherence

Serve as a key advisor to product marketing teams

Guide the development and implementation of compliant promotion and marketing strategies

Ensure all marketing activities align with legal and compliance obligations

Identify compliance training needs across the organization

Develop and deliver comprehensive compliance training programs according to a defined schedule for all affected disciplines and functional areas

Provide ongoing support to reinforce global compliance efforts

Offer guidance on US transparency law requirements, including but not limited to: Physicians Payments Sunshine Act, State-specific laws (e.g., Massachusetts and Vermont)

Support and coordinate global reporting activities to ensure transparency compliance

Qualification

Juris DoctorFDA regulations knowledgeCompliance Certification(s)Global compliance experienceMedical device complianceThird party managementCultural awarenessSoftware proficiencyEnglish proficiencyOrganizational skillsCommunication skills

Required

Juris Doctor required from an accredited school within the region where the role resides

Eligibility for registration to practice law in the primary location of employment

Minimum 15 years experience in relevant compliance work with a portion of this time spent in a law firm or within a company

Minimum of 8 years of management experience in compliance in the medical device, pharmaceutical or related life sciences industry

Third party management experience required

Strong knowledge of FDA regulations and U.S. and international healthcare laws, including without limitation Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practices Act and foreign equivalents

Extensive experience supporting a global legal function with diverse responsibilities across various aspects of international business operations

Exceptional English language proficiency, both written and verbal

Demonstrated ability to interact effectively with personnel at all organizational levels

Proven track record of working successfully with individuals from diverse cultural backgrounds

Capability to work autonomously while coordinating efforts with other attorneys, functional teams, and company leadership

Superior organizational skills and attention to detail

Proficiency in relevant software applications and the ability to leverage technology effectively in a professional setting

Exemplary communication skills, both oral and written, with the ability to convey complex legal concepts clearly and concisely

Preferred

Compliance Certification(s) preferred

Company

Terumo Blood and Cell Technologies

Glassdoor3.4

Headquartered in Lakewood, Colorado, Terumo Blood and Cell Technologies is a global leader in blood component, therapeutic apheresis and cellular technologies serving customers in more than 150 countries.

Founded in 1964

Lakewood, Colorado, US

5001-10000 employees