04 ott - Verona
Orthofix Holdings
Junior Regulatory Product Maintenance specialistApply: Verona - Bussolengo: Tempo pieno: Posted Yesterday: OFX26331Why Orthofix?Guided by our organizational values – Take Ownership | Innovate Boldly | Win Together – we collaborate closely with world-class surgeons and other partners to improve people’s quality of life. 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. Looking to change people’s lives? Look no further.We are looking for a Junior Regulatory Product Maintenance specialist to join our Regulatory Affairs team, based in Bussolengo (Verona) on a temporary contract of 1 year.
You will report to the Regulatory Affairs Manager.You will be collaborate with Regulatory Technical Product and RA Administrative specialists to assure that the Product Technical documentation Files and related documentation are up to date in compliance to the international regulatory requirements in time with deadline.Responsibilities include collaboration with all internal departments, consultants, subsidiaries, distributors, external laboratories and suppliers for successful regulatory activities in each impacted area. What will your contribution be?* Assures, that the Regulatory Technical documentation on paper or on electronic relevant to a new or modified products is adequately updated and archived in the proper Technical File (DMF) and indexes are up to date.* Maintain UpToDate Regulatory EU Product Technical Files and FDA Product Applications File in collaboration with departments, complete and accurate and available for regulatory Product(s) Applications International submission on time to the pla
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