Lead Specialist, RAQA

Full-time Management & Operations

Position Summary

Develops and applies intermediate knowledge and understanding of the Post-Market Surveillance (PMS) and RAQA frameworks, legislative requirements, processes and procedures in the EMEA distribution organisation.

Key Activities & Accountabilities

• Executes PMS and RA QA activities in line with defined procedures and processes.
• Collects, organises and maintains files on local, regional, and global RAQA intelligence.
• Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation.
• Suggest opportunities for continuous improvement and supports those activities across RAQA.
• Performs based on established targets, KPIs and objectives for PMS and RAQA.
• Provides support to EMEA / Country RAQA teams as appropriate.
• Support local RAQA Leader to collect data relevant for reporting performance, risks and issues to local leadership teams.
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