Senior Regulatory and Quality Systems Specialist -Remote

REMOTE Senior Regulatory and Quality Systems Specialist – 12 Months+ contract

Leading medical device manufacturing company

• Co-ordinates and prepares document packages for regulatory submissions from all areas of the organization with a focus and priority on EUMDR EUDAMED UDI.
• Collects all materials required in submissions, license renewal, and annual registrations for EUDAMED UDI.
• Keeps abreast of regulatory procedures and changes. May interact with regulatory agencies.

• Seeking a candidate with more direct Quality Systems and UDI experience.
• Ability to write and release quality systems procedures for how to gather, organize, and submit EUDAMED UDI information in support of EUMDR,
• Ability to easily organize, manipulate and manage complex EUDAMED UDI data,
• Familiarity with submitting UDI information to both internal company repositories and external regulatory agencies, ability to design and implement controlled processes and methods to correct EUDAMED UDI data quality issues and keep metrics of data quality and data quality improvements to demonstrate effective corrections and corrective actions, and ability to coordinate and implement common EUDAMED UDI processes across division sites.
• Experience with MS Office tools essential.
• Experience with PLM, Document Control, and ERP systems a plus.
• Experience designing, implementing, and using workflow/approval processes also a plus.

SDL2017