Product Development Post-launch Technical Leader

TL;DR

Product Development Post-launch Technical Leader (IVD): Oversees technical initiatives for launched products and those undergoing registration in multiple countries, ensuring effective handling of regulatory requests and compliance. Focus on planning and executing IVD validation activities, conducting scientific literature reviews, preparing technical documentation, and leading a small dedicated team.

Location: Saluggia, Italy

Company

Global leader in diagnostic solutions with over 50 years of experience developing innovative assays and instruments.

What you will do

• Manage technical requests from Regulatory Authorities during registration, changes, or renewals.
• Oversee technical initiatives for launched products and those under registration across countries.
• Plan and execute IVD validation activities aligned with company strategy, including performance evaluations and IFU updates.
• Conduct scientific literature reviews and prepare compliant technical documentation.
• Provide technical expertise for post-launch strategies and coordinate with Regulatory Affairs.
• Lead a small team, allocating tasks and ensuring alignment with timelines and objectives.

Requirements

• Scientific or technical/biomedical University Master’s degree.
• Minimum 2 years experience in IVD validation, ideally in diagnostics or pharma.
• Understanding of regulatory requirements for in vitro diagnostic medical devices.
• Planning, problem-solving, and cross-functional interaction skills.
• Fluent in written and spoken Italian and English

Culture & Benefits

• Impactful work improving patient care through global healthcare solutions.
• Collaborative environment with international colleagues.
• Diverse and inclusive culture valuing unique perspectives.