TERUMO BCT, INC
Director, Deputy Chief Compliance Officer
TERUMO BCT, INC, Lakewood, Colorado, United States,
Director, Deputy Chief Compliance Officer
Location:
Lakewood, CO, US Requisition ID:
32880 At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world.
For Terumo, for Everyone, Everywhere. We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve.
Advancing healthcare with heart. With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference.
Join us and help shape wherever we go next. You create your future and ours. JOB TITLE
: Director, Deputy Chief Compliance Officer REPORTS TO:
General Counsel JOB SUMMARY The Deputy Chief Compliance Officer is responsible for developing, implementing, and maintaining a robust and effective global compliance program for TBCT, ensuring adherence to all applicable laws, regulations, and industry standards, with a focus on third-party management and HCP interactions and engagement. Work in collaboration with international compliance team members to ensure our company's adherence to company policies and all legal and regulatory compliance requirements in the medical device industry. ESSENTIAL DUTIES Global Compliance Program Management:
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. Implementing measures to prevent, detect and correct illegal, unethical, or improper conduct. Develop and execute global Compliance Action Plans Provide compliance support for quality and regulatory matters
Lead the Global Compliance Team:
Oversee daily operations Assign tasks and projects Monitor team performance Coordinate external compliance resources Evaluates and supports regional compliance meetings
Conduct periodic risk assessments and audits Develop preventative and corrective action plans Assist with cybersecurity efforts Contribute to data privacy initiatives Participate in enterprise risk management Global Compliance Policy Management:
Establish, implement, and oversee worldwide compliance-related policies and procedures Collaborate closely with legal and compliance associates Focus on health care regulatory compliance, data privacy compliance, and other related matters Ensure policies align with international regulations and company standards
Global Associate Complaint System:
Manage and maintain the company-wide complaint system Ensure all complaints are addressed promptly and effectively Prepare and deliver regular reports to TC and EMC on complaint status and resolutions Conduct root cause analysis for repeated complaints Oversee high level investigations
Cross-Functional Compliance Support:
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
Medical Device Compliance:
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
Marketing Compliance Advisory:
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
Global Compliance Training and Support:
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
Transparency Law Compliance:
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
MINIMUM QUALIFICATION REQUIREMENTS Education 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. Experience 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 experience in compliance in the healthcare industry. HCP/HCO and third party management experience required. The equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Skills 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. -Or- An equivalent competency level acquired through a variation of these qualifications may be considered. Certificates, Licenses, Registrations Compliance Certification(s) preferred. PHYSICAL REQUIREMENTS Typical Office Environment requirements include: reading, speaking, hearing, close vision, traverse, bending, sitting, and occasional lifting up to 20 pounds. The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Additional Physical Requirements Travel required up to 15% Target Pay Range:
$191,100.00 to $238,900.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data Target Bonus on Base:
30.0% At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan. In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue. We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo. We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries. Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare:
Respect – Appreciative of others Integrity – Guided by our mission Care – Empathetic to patients Quality – Committed to excellence Creativity – Striving for innovation
We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007. We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service. Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.
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Location:
Lakewood, CO, US Requisition ID:
32880 At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world.
For Terumo, for Everyone, Everywhere. We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve.
Advancing healthcare with heart. With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference.
Join us and help shape wherever we go next. You create your future and ours. JOB TITLE
: Director, Deputy Chief Compliance Officer REPORTS TO:
General Counsel JOB SUMMARY The Deputy Chief Compliance Officer is responsible for developing, implementing, and maintaining a robust and effective global compliance program for TBCT, ensuring adherence to all applicable laws, regulations, and industry standards, with a focus on third-party management and HCP interactions and engagement. Work in collaboration with international compliance team members to ensure our company's adherence to company policies and all legal and regulatory compliance requirements in the medical device industry. ESSENTIAL DUTIES Global Compliance Program Management:
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. Implementing measures to prevent, detect and correct illegal, unethical, or improper conduct. Develop and execute global Compliance Action Plans Provide compliance support for quality and regulatory matters
Lead the Global Compliance Team:
Oversee daily operations Assign tasks and projects Monitor team performance Coordinate external compliance resources Evaluates and supports regional compliance meetings
Conduct periodic risk assessments and audits Develop preventative and corrective action plans Assist with cybersecurity efforts Contribute to data privacy initiatives Participate in enterprise risk management Global Compliance Policy Management:
Establish, implement, and oversee worldwide compliance-related policies and procedures Collaborate closely with legal and compliance associates Focus on health care regulatory compliance, data privacy compliance, and other related matters Ensure policies align with international regulations and company standards
Global Associate Complaint System:
Manage and maintain the company-wide complaint system Ensure all complaints are addressed promptly and effectively Prepare and deliver regular reports to TC and EMC on complaint status and resolutions Conduct root cause analysis for repeated complaints Oversee high level investigations
Cross-Functional Compliance Support:
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
Medical Device Compliance:
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
Marketing Compliance Advisory:
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
Global Compliance Training and Support:
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
Transparency Law Compliance:
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
MINIMUM QUALIFICATION REQUIREMENTS Education 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. Experience 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 experience in compliance in the healthcare industry. HCP/HCO and third party management experience required. The equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Skills 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. -Or- An equivalent competency level acquired through a variation of these qualifications may be considered. Certificates, Licenses, Registrations Compliance Certification(s) preferred. PHYSICAL REQUIREMENTS Typical Office Environment requirements include: reading, speaking, hearing, close vision, traverse, bending, sitting, and occasional lifting up to 20 pounds. The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Additional Physical Requirements Travel required up to 15% Target Pay Range:
$191,100.00 to $238,900.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data Target Bonus on Base:
30.0% At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan. In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue. We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo. We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries. Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare:
Respect – Appreciative of others Integrity – Guided by our mission Care – Empathetic to patients Quality – Committed to excellence Creativity – Striving for innovation
We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007. We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service. Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.
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