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Senior Counsel, Regulatory & Compliance - North America

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Date: Sep 23, 2022

Location: Lakewood, US

Company: Terumo BCT, Inc.

Requisition ID:  28879  

 

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.

 

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.

 

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. Consider joining our team and unlock your potential. 

Senior Counsel, Regulatory and Compliance, North America

 

JOB SUMMARY

Working without significant direction, provides legal and compliance expertise to the business on complex federal and state regulatory and compliance matters, with an emphasis and focus on laws, regulations and industry codes relating to medical device, and generally health care or pharma.  Demonstrates leadership in legal and regulatory advising, compliance-sensitive contract drafting, and compliance program development and management. This position reports to the General Counsel, Chief Compliance Officer in Lakewood.

 

ESSENTIAL DUTIES

  • Provides legal advice and counsel to the relevant business or functional areas, including Commercial Excellence, Regulatory, Clinical and Sales and any others as required, with limited direction from his or her supervisor
  • Coordinates and oversees the work product of legal support staff dedicated to medical device compliance related activities in North America, including familiarity and compliance with the AdvaMed Code.
  • Independently applies legal principles and judgment to the solution of highly complex legal and compliance issues
  • Establishes, implements and manages policies and procedures for the within North America, in coordination with legal and compliance associates outside of North America, related to health care regulatory compliance, data privacy compliance, as well as other compliance related matters 
  • Serves as legal advisor to all North America product marketing teams on development and implementation of promotion and marketing strategies that are consistent with our legal and compliance obligations, and is responsible for legal and compliance review of promotional and marketing materials
  • Provides advice and counsel related to field actions, including customer communications and recalls.
  • Identifies, provides training and works to support compliance efforts within the North America.
  • Leads management, leads training, and provides advice and counsel with respect to, US transparency law requirements (including, without limitation, the Physicians Payments Sunshine Act, and similar laws in states such as Massachusetts and Vermont)

 

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

Juris Doctorate required from an accredited school in the United States where the role resides; admission and in good standing in at least on state bar, with eligibility to be admitted to Colorado.

 

Experience

Minimum 7 years of experience in relevant legal work with a portion of this time spent in a law firm or within a governmental agency.  Health care, pharma or medical device (preferred) industry experience required. The equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

 

Requires registration to practice law in at least one state in the U.S., and must be licensed in the state the attorney is primarily located.

 

Skills

  • Demonstrated experience supporting a global legal function with multi-faceted responsibilities across the spectrum of a global business.
  • Requires strong English language skills, both written and verbal.
  • Requires strong legal document drafting and negotiating skills.
  • Requires ability to interact effectively with employees at all levels of the business.
  • Requires the ability and experience working with persons from other cultures, preferably within the context of legal work abroad.
  • Requires ability to work independently while coordinating with other attorneys and Company management.
  • Requires strong organization skills.
  • Knowledge and use of relevant PC software applications and skills to use them effectively.
  • Demonstrated ability to communicate effectively both verbally and in writing.

 

PHYSICAL REQUIREMENTS

Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, 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.

 

 

Target Pay Range:  $152,800.00 to $191,000.00  -  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:  20.0%

 

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. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

 

  • 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. Absent accommodation permitted by applicable law, as a condition of employment with Terumo Blood and Cell Technologies in the United States you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.


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