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Regulatory Affairs Specialist

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Date: Sep 8, 2021

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  28037  

 

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. 

JOB SUMMARY

Working without significant direction, assists in fulfilling Regulatory compliance requirements by applying a thorough understanding of Regulatory standards to one or more areas of expertise such as regulations for medical devices, pharmaceuticals, or biologics.

 

ESSENTIAL DUTIES

  • Using a broad base of knowledge and understanding of regulatory requirements, assumes major responsibility for one or more major regulatory affairs areas
  • Identifies and defines contents for Regulatory submissions.  Leads the assembly and creation of these documents for their timely submission to Regulatory authorities.
  • Maintenance of sometimes complex existing licenses/certificates, product approvals, and post market notifications.
  • Responsible for overall compliance with Regulatory requirements that apply to the product development cycle.  Makes recommendations on how to achieve compliance.
  • Works with manufacturing, engineering, and other functional groups on Regulatory compliance issues.
  • Applies standard procedures and learned knowledge to develop regulatory solutions of moderate to low complexity within established guidelines.  May collaborate with individuals at different levels in solving problems that are routine in nature. Interprets, executes, and recommends modifications to operating policies where appropriate.
  • The effect of Regulatory support offered to internal customers may be critical to the short-term and intermediate objectives of the department

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

Bachelor’s degree in physical/biological sciences or engineering preferred, or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

 

Experience

Minimum 4 years experience in Regulatory Affairs.

 

Skills

  • In depth knowledge of U.S. and/or international medical device and/or pharmaceuticals and/or biologics regulations and standards
  • Working knowledge of and ability to prepare regulatory documentation in compliance with regional regulatory requirements
  • Familiarity with regulatory standards and demonstrates general knowledge with individual products/geographies
  • Demonstarted ability to author sections of a regulatory submission under supervision, with content review at end
  • Qualified within the Regulatory function with limited to moderate understanding of the basic principles, theories, practices, and concepts within the Regulatory function
  • Able to identify adequacy of submission sections and overall content of submissions. Able to identify gaps and suggest solutions.
  • Knowledge and use of relevant PC software applications and skills to use them effectively.
  • Demonstrated ability to communicate effectively both verbally and and in writing.
  • Must be highly skilled in timely and accurate decisions. Demonstrated analytical and creative thinking skills and the ability to solve complex problems.

 

Certificates, Licenses, Registrations

Quality Assurance or Regulatory Affairs Certification (RAC) desired

 

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:  $80,000 to $100,000  -  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:  7.0%

 

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. 


Nearest Major Market: Denver

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