R-005-003 Work Leave Coordination - Jordi Barrachina
Leave start date: 2025-05-01
Gantt chart
Ongoing projects
San Pau study
Description: Clinical study being conducted in collaboration with Hospital de Sant Pau.
Role and responsibilities: Clinical oversight and coordination of the study documentation and communication with the site.
Current status: The study is in a monitoring phase with no significant activity expected.
Expected milestones: No major milestones are expected during the absence. The site may occasionally raise queries, which are typically operational in nature.
Contingency guidance: If the hospital contacts us with a question, queries are usually about data clarification or protocol interpretation. Escalate to the project lead.
Interim owner: To be assigned by direct manager.
BSI clinical responses
Description: Preparation and submission of responses to BSI regarding the clinical evaluation section of the technical documentation.
Role and responsibilities: Drafting and reviewing the clinical responses to BSI's questions on the clinical evidence.
Current status: Responses have been submitted. We are awaiting BSI's reply.
Expected milestones: BSI is expected to respond approximately in June 2025. If they raise non-conformities, the response can likely be prepared within two weeks.
Contingency guidance: If BSI responds with non-conformities during the absence, Saray or Taig can handle the initial review by consulting the existing documentation folder and coordinating with Brendan.
Interim owner: To be assigned by direct manager.
FDA pre-submission
Description: Preparation of the FDA pre-submission (pre-sub) documentation for regulatory clearance in the United States.
Role and responsibilities: Drafting the pre-submission document and coordinating with Brendan on the regulatory strategy.
Current status: The pre-submission is in preparation.
Expected milestones: The pre-submission should be finalized and submitted. Once submitted, FDA feedback is expected approximately 30 days later. Upon receiving feedback, the response should be reviewed internally and discussed with Brendan.
Contingency guidance: If the pre-submission needs final review or if FDA responds during the absence, Taig can review the document and coordinate with Brendan on the response strategy.
Interim owner: To be assigned by direct manager.
Signature meaning
The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:
- Author: Team members involved
- Reviewer: JD-003 Design & Development Manager, JD-004 Quality Manager & PRRC
- Approver: JD-001 General Manager