Data Specialist, MDR

Teleflex Medical Europe
Employment Type
Not disclosed
Teleflex Medical Europe logo

This will be a 2-year fixed term role 

Job Purpose: 

The Data Specialist, MDR will be part of the Project Team for MDR Regulatory. This position is the Project Lead for UDI. This person will lead in the verification of UDI per MDR on labels, artwork and documentation for Medical Devices coming from suppliers. They will also lead the coordination of the gathering and loading of UDI data into the UDI Data Management Systems.

Key Responsibilities: 

•Perform review and verification of supplier’s product labels, artwork and documentation to check if they are in compliance with the UDI requirements as required by MDR regulations, GS1 Standards and Teleflex SOP’s

•Collaborate with Teleflex suppliers as required

•Coordinate the gathering of data in Excel format from all applicable parties for the UDI Data Management System. 

•Perform various tasks on UDI Data Management Systems, Data Sync Direct application including:

  • Preparation of large volumes of data for loading to Data Sync Direct 
  • Review Error reports and validations to correct data loads 
  • Perform pre and post load review and approvals
  • Maintain UDI Data on Data Sync Direct and make changes and updates as required

•Perform review of Product Specifications and Supplier Quality Agreements regarding UDI data and responsibilities as required.

Essential Skills / Experience: 

•Engineering/Science qualification with at least 3-5 years of working in a medical devices environment – preferable.

•Ability to communicate and operate effectively with multiple teams.

•MS-Office (primarily Word, Excel, Outlook, etc.).

•Attention to detail and accuracy – essential.

•Ability to manage large volumes of data.

•Prioritize tasks and be able to manage several tasks simultaneously.

•Ability to work well under deadlines and pressure.

•Adapt to shifting priorities, work with minimal supervision, resolve problems/conflicts, and demonstrate solid reasoning ability.

Key Relationships / Interfaces: 

•Supplier Quality – MDR Operations Team

•Quality Management teams 

•Regulatory Affairs

•Global Procurement 

•Buyers/ Purchasing Organisation 

•Suppliers of Finished Devices

Behaviours / Values: 

•Approachable and enthusiastic, flexible and adaptable.

•Ability to work off own initiative and as a team player. 

•Good organizational skills with cultural awareness and sensitivity. 

•Good judgment and problem-solving ability, with capability of understanding the impact of decision making on both Teleflex Medical and their customers.

•Strong collaboration and influencing skills – both internally and externally.

•Excellent communication skills – both written and verbal.

•Goal orientated for customer and business objectives.

Note: As with all positions, due to the dynamic nature of Teleflex Medical Business, key responsibilities will evolve and change over time. Teleflex is an equal opportunities employer.