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UDI Process Owner

Date: Aug 7, 2019

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  23449  

 

Understand and implement global requirements for UDI, GUDID, and EUDAMED. Position is responsible for building and maintaining the central database of product data and ensures a high quality of data is inputted and fields are entered correctly with the highest of data integrity.

ESSENTIAL DUTIES

  • Create master project plan and strategy for compliance with GUDID, EUDAMED including UDI under MDR, and other databases being developed for other countries, e.g. China, S. Korea, Australia, etc.
  • Develop and implement a strategy for how data attributes will be collected, managed, stored and submitting to databases globally.
  • Identify resources and tools required to collect the data attributes in scope by the EU MDR deadline of May 26, 2020.
  • Lead the execution of the activities in collecting, verifying, approving and maintaining the integrity of data attributes.
  • Develop and implement a strategy for submitting data considering 3rd-party options.
  • Setup and manage relationship with 3rd party for submitting data.
  • Implementing the process into global QMS
  • Training associates globally as needed to comply with new procedures.
  • Become lead contact with EUDAMED/eIFU corporate team and sharing project status.
  • Collaborate with EUDAMED/eIFU business group teams as needed and provide oversight for project progress, status reports and timely completion.
  • Coordinate priorities with other EU MDR work streams to feed into the overall success of the EU MDR program.
  • Escalate issues quickly to ensure high quality project delivery.

MINIMUM QUALIFICATION REQUIREMENTS

Experience

Minimum 7 years experience working in medical device industry or equivalent, proven track record of successful project management experience.

  • Experience and knowledge with UDI and GUDID desireable
  • eIFU experience a plus
  • Experience working with multiple teams at different global sites and complex systems
  • Well-versed in program and project management tools and practices
  • Knowledge of quality systems and EU regulatory requirements including the MDD and MDR for medical devices required

Skills

  • Excellent communication skills.
  • Ability to drive the projects without authorities.
  • Ability to rapidly build product knowledge and understanding of technical and scientific regulatory activities.
  • Project Management skills and experience.
  • Knowledge of FDA 21 CFR Part 820, ISO 13485.
  • Highly IT literate, with knowledge of MS excel and office suite.
  • Capable of understanding large data sets.
  • Stakeholder engagement skills.
  • Self-motivated and checks over own work prior to passing along for review.
  • Professional, competent, and able to work as part of a cross functional team.
  • Knowledge and use of relevant PC software applications and skills to use them effectively.
  • Demonstrated ability to communicate effectively both verbally and in writing.

 

Education

Bachelor’s degree in Life Science or technical discipline, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered

 

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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