UDI Process Owner

Employer
Terumo BCT
Location
Lakewood, CO
Posted
Aug 15, 2019
Required Education
Bachelors Degree
Position Type
Full time

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