Medical Device Project Manager - 17235

Assignment Description

We are looking for a Senior Project / Program Manager

What You Will Work On

Establish and lead a regulatory gap-closure program across multiple product areas
Translate regulatory gap analyses into structured and actionable work packages
Coordinate cross-functional execution across QA/RA, Engineering, Product, and Documentation teams
Ensure remediation activities follow Design Control requirements (ISO 13485)
Link remediation work to Change Control, CAPA processes, and DHF/DMR updates
Manage dependencies, risks, and resource constraints across multiple workstreams
Provide executive-level reporting on progress, risks, and decision points
Prepare decision materials for steering committees and leadership forums
Drive structured execution and ensure audit readiness across all activities

What You Bring / Required Qualifications

Proven experience delivering regulatory remediation, audit response, or gap-closure programs
Strong knowledge of ISO 13485 and EU MDR
Experience with FDA QSR / QMSR (preferred)
Experience working with design control processes, including retrospective remediation
Ability to coordinate across multiple products and organizational units
Experience working in cross-functional environments with QA/RA, engineering, and product teams
Strong ability to manage complex programs with multiple dependencies
Fluent in English, both written and spoken

If this sounds interesting, please send your CV to cv@veritaz.se

Medical Device Project Manager – 17235