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Associate Regulatory Affairs Specialist

Date: Aug 14, 2019

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  23683  

 

Working under minimal supervision, provides Regulatory support by assisting management or project teams in complying with worldwide Regulatory requirements.  Associate has basic knowledge and skills in Regulatory pathways, options and documentation requirements to support portions of a project or a Regulatory filing.

 

ESSENTIAL DUTIES

  • Performs varied Regulatory activities such as gathering content for a Regulatory filing, reviewing relevant guidance, and reviewing data to ensure accuracy for Regulatory filing purposes or in support of regulatory databases used to support the organization
  • Works independently to accomplish established Regulatory objectives following specific aspects of selected Regulatory strategy  
  • With training, can support maintenance of existing simple licenses/certificates and assist with the compilation of submission
  • Develops or participates in the development of Regulatory solutions to problems involving several concrete variables in, or from, standardized situations of moderate to low complexity that may affect a narrow functional area
  • May work with manufacturing, engineering, and other functional groups to gather Regulatory content for Regulatory filings or to address a potential Regulatory compliance issue
  • Maintains regulatory required records per record retention requirements, assisting with maintaining submission databases and archiving
  • Updates and maintains Regulatory filing history for a given product line
  • The scope of Regulatory support offered to internal customers may be related to the short-term and intermediate objectives of the department

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

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

 

Experience

Minimum 2 years experience working in Regulatory Affairs, Quality Assurance or another regulated environment.

 

Skills

  • Requires learned knowledge plus limited understanding of the basic principles, theories, practices, and concepts of Regulatory Affairs
  • Basic knowledge and skills in regulatory pathways, options, and documentation with portions of projects
  • Possess interpersonal and organizational savvy
  • Knowledge and use of relevant PC software applications and skills to use them effectively
  • Demonstrated ability to communicate effectively both verbally and in writing

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

 

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.

 

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 BCT is committed to providing a safe and secure working environment.  We maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification checks.  To this end, all employment offers for positions in the U.S. are conditional upon successful completion of Terumo BCT's pre-employment screening process.  As of January 1, 2017 the Terumo BCT Lakewood, Colorado location will be a tobacco-free workplace. For more information about Terumo BCT, visit our website www.terumobct.com/careers.


Join Terumo BCT as we unlock the potential of blood. We are a global leader in blood component and cellular technologies, and the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.

 

As the largest medical device manufacturing company headquartered in Colorado, we are home to more than 2,300 associates and our products are in use in more than 125 countries and territories. Our Global footprint includes more than 5,500 associates and partners with regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.

 

Our company has almost $1B in annual revenues and has been voted and recognized as:

  • Largest corporate sponsor in Rocky Mountain Region for Leukemia and Lymphoma Society (LLS)
  • Winner of the Association for Talent Development (ATD) BEST Award for providing exceptional employee learning and talent development (2011 & 2012)
  • One of Colorado’s Healthiest Employers by Denver Business Journal (2014 & 2015)
  • Recipient of the Way to Go Employer award through the Denver Regional Council of Governments (DRCOG) 2015

 

Our award-winning culture embraces:

  • Leading technology through innovation and R&D
  • Wellness programs
  • Commitment to quality
  • An environment that values, respects and rewards your individual contributions
  • A philosophy of intentional growth and responsiveness to world health issues

 

Click Here to see what our associates have to say about our culture.

 

Each associate has a positive impact on our future by:

  • Connecting to the lives of the patients we ultimately serve
  • Growing through professional and leadership development activities
  • Sharing company success through incentive plans

 

If you are the best at what you do and want to do work that is changing the delivery of healthcare globally, we invite you to work with us now to see how we can unlock your potential.


Nearest Major Market: Denver

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