Product Development Post-launch Technical Leader

DiaSorin

Diagnostics

Saluggia - Italien

Manager / Team Leader

Experteer Overview

In this role you drive technical initiatives for existing and registering products across countries, guiding regulatory interactions and validation activities. You lead a small team within Product Development Immuno to ensure compliant, timely scientific work, from validation to post-launch support. You will shape technical documentation and stay ahead of evolving regulatory expectations for IVDs. This is a chance to impact global healthcare solutions through rigorous scientific leadership and cross-functional collaboration.

Responsibilities

Manage technical requests during submissions and regulatory transitions
Oversee initiatives for launched and registering products across multiple countries and changes
Ensure compliance with GOPs/SOPs and quality standards
Maintain up-to-date expertise on regulatory requirements for IVDs across regions
Plan and execute IVD validation activities and related technical documentation (e.g., Performance Evaluation, IFU updates)
Provide technical guidance to Product Development for post-launch strategies
Conduct and supervise scientific literature reviews
Lead a dedicated team with clear planning, task allocation, and alignment to timelines and regulatory needs
Coordinate with Regulatory Affairs during submission processes

Key requirements

Master's degree in a scientific/biomedical field
Minimum of two years of experience in IVD validation
Understanding of mandatory regulatory requirements for IVD medical devices
Strong planning, problem-solving, and cross-functional interaction skills
Fluent in Italian and English

planning cross-functional collaboration problem-solving IVD validation regulatory compliance for IVDs technical documentation (Performance Evaluation, IFU updates)

Description

In this role you drive technical initiatives for existing and registering products across countries, guiding regulatory interactions and val…

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