Global Regulatory Strategist – Medical Devices

pOrthofix is seeking a Senior International Regulatory Specialist to join the Regulatory Affairs team in Italy. You will manage international product submissions, ensure regulatory documentation is up to date, and collaborate with QA, RD, and global colleagues to achieve timely registrations across markets. /ppThe role involves interacting with authorities,...

Overview In this senior regulatory role, you provide strategic legal guidance across the lifecycle of Illumina’s medical devices, diagnostics, and life-science products in EMEA and Latin America. You collaborate with cross-functional teams to enable compliant product development, submission, and post-market activities in a fast-paced, international...

Chi siamo ENOVIS™ Enovis Corporation (NYSE: ENOV) è un'azienda in crescita nel settore delle tecnologie mediche orientata all'innovazione e dedicata allo sviluppo di soluzioni clinicamente differenziate che migliorano in modo misurabile i risultati dei pazienti e trasformano i flussi di lavoro. Grazie a una cultura del miglioramento continuo, al talento...

Regulatory CMC Technical Lead Consultant Italy Regulatory CMC Technical Lead Consultant Job Description: * Maintain or create CMC regulatory documents for the dedicated product(s) to support a broad range of submissions to Regulatory Authorities. * Manage CMC regulatory documents for the dedicated product(s) in close collaboration with the Core team, with...

OverviewQuality Assurance Regulatory Affairs (QARA) Specialist – Dedalus. Remote in Italy. Part of the Global Quality and Assurance Team to drive quality and regulatory excellence in healthcare technology.What you’ll achieveAs a QARA Specialist you will ensure compliance with Quality and Regulatory standards across the company, contributing to better...

Sinclair is Hiring! Join Our Team as a Risk Manager. We are currently recruiting for Risk Manager. The Risk Manager will report to the R&D Director and contribute directly to meeting regulatory submission, launch timelines of medical devices and aesthetic products as well as regular review activities. The Risk Manager is responsible to maintain risk...

Overview In this role, you will lead the industrialization, validation and lifecycle management of Device Constituent Parts and device platforms, ensuring scalable, compliant development and technology transfer. You will drive cross-functional alignment across R&D, Quality, Regulatory, Manufacturing, and external partners to secure regulatory compliance and...

Quality Assurance Assistant# Envista Careers## Quality Assurance AssistantApply: ITA - Scafati (SA) - Kerr Italia S.r.l.: Full time: Posted Today: R5027752**Job Description:**# **Key Responsibilities*** Review manufacturing and quality documentation and perform final review and disposition of Device History Records, batch records, or lot history...

Technician Quality Control# Envista Careers## Technician Quality ControlApply: ITA - Scafati (SA) - Kerr Italia S.r.l.: Full time: Posted Today: R5027750**Job Description:****Key Responsibility:*** Review documentation for SOP, Test Instruction and Calibration Procedure.* Final review & release of Medical Device History Records (DHRs).* Identify and...