Regulatory Affairs Analyst
- 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.
- Works on problems of complex scope where data analysis requires evaluation of specific factors.
- Utilizes independent judgment within broad parameters to determine an appropriate solution.
- May determine methods and procedures on new projects and may provide guidance to other lower-level staff.
- This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision.
- Roles typically require a university degree or an extensive amount of practical knowledge gained through experience.
- Job requires an understanding and application of procedures and concepts of own discipline.
- The job requires attention to detail in making evaluative judgements based on the analysis of factual information.
- This job typically requires a degree or equivalent and a minimum of 2 or more years experience.
- We are looking for someone with more direct Quality Systems and UDI experience than the prior contractor in this role.
- Specifically we are looking for someone with the 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.