Medical Device Project Manager 17235

Veritaz is a leading IT staffing solutions provider in Sweden, committed to advancing individual careers and aiding employers in ensuring the perfect talent fit. With a proven track record of successful partnerships with top companies, we have rapidly grown our presence in the USA, Europe, and Sweden as a dependable and trusted resource within the IT industry. 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