Post Market Surveillance Specialist, Gbs (Bogotá)

What You Can Expect

The Post Market Surveillance Specialist is document owner for Post Market Surveillance Activities; will document PMS Plans and, if the case, PMS Reviews (PSURs or PMSRs) records according to the applicable regulations (including MDR (EU) 2017/745); he/she will be responsible for working with Regulatory Affairs to ensure documentation has been reviewed and aligned with Notified Body (when applicable). The PMS specialist ensures Post Market Clinical Follow-up (PMCF) commitments are clearly documented within relative PMSPs, informed within clinical research department, and aligned with Notified Bodies. Scheduling and coordination of PMS teams for review of proactive and vigilance activities according to schedule; gathering inputs from cross functional stakeholders, and elevating at‑risk findings to senior management. Track execution of PMS plans according to requirements; report to the manager on track, delayed and at‑risk PMS commitments; project manage...