Post Market Surveillance Specialist

Job description

Work Flexibility: Hybrid What You Will Do: - Executes PMS activities in accordance with established procedures, processes, and regulatory requirements. - Coordinates the blocking and unblocking of medical devices impacted by Commercial Holds or PFAs in the ERP system, upon request from the Legal Manufacturer. - Ensures the products and the customers impacted by a Commercial Hold or a PFA are properly identified - Initiates and manages product quarantines and releases related to Commercial Holds and PFAs. - Ensures timely and accurate communication of PFAs and Commercial Holds to local business teams and key stakeholders. - Performs final lot reconciliation and proactively resolve discrepancies related to PFAs and Commercial Holds, in collaboration with cross-functional departments. - Manages the end-to-end Product Complaint Handling process for the CEE region, including timely opening, follow-up investigation, and closure of complaints. - Obtains complete and accurate supporting information from customers and internal stakeholders to enable effective product complaint investigations. - Prepares and issues complaint closure letters to customers, where applicable. - Facilitates effec...