At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the unrivaled partner in Med Tech.
Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. We are looking for a Technical Product RA Specialist to join our Regulatory Affairs team, based in Bussolengo (Verona) as a maternity substituition . You will report to the Regulatory Affairs Manager.
You will be responsible to assure availability of Technical Documentation File by preparing and maintain up to date the regulatory Product Application Files applicable for any new or modified Products. (EU-MDR Technical Documentation File, FDA 510(k))




Responsibilities include collaboration with Quality Engineering and R&D; Departments and other functional areas in the application of all identified regulatory requirements for ensuring Technical Product Documentation File is adequate and accurate for successful regulatory submissions and approvals in each impacted country.
You will be a member of the NPI team and Product Reviews Board, by participating, prepare and assure that the regulatory deliverables are duly prepared during the NPI - Reviews processes in due time.
You will edit and amends the Technical File structure and verifies regulatory conformity of Technical documentation in collaboration with Quality Engineering and R&D; necessary for Products application submission in EU, US and ROW countries, as required.
As member of the Technical Review Board you will work closely with any specific department for new/modification products and design changes by transferring the identified Product input regulatory requirements to ensure proper and adequate technical documentation for product registration/licensing in respect to planned timeline.
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📌 Technical Product RA Specialist (Italia)
🏢 PVH (Tommy Hilfiger/Calvin Klein)
📍 Italia