h3Why Orthofix? /h3 pGuided by our organizational values – bTake Ownership /b | bInnovate Boldly /b | bWin Together /b – 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 _ bunrivaled /b _ partner in Med Tech. /p pOur 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. /p pWe are looking for a bJunior International Regulatory Specialist /b to join our bRegulatory Affairs /b team, based in Bussolengo (Verona) on a maternity substitution contract. You will report to the bRegulatory Affairs Manager. /b /p pYou will collaborate with Regulatory International area and RA Administrative specialist to assure International Product/facility(ies) application submissions including international registrations and/or license applications, are up to date in compliance to the international regulatory requirements and in time with requested deadline. /p pResponsibilities include collaboration with all internal departments, consultants, subsidiaries, distributors, external laboratories and suppliers for successful regulatory activities in each impacted area. /p h3What will your contribution be? /h3 ul liAssures, that the Regulatory International documentation on paper or on electronic relevant to a new or modified products is adequately updated for International Products applications. /li liProvide in timely manner any regulatory product registration/submission information status to able to update the Regulatory file platform /data on time. /li liPrepare and maintain updated Procedure Pack Files. /li liAs needed,



support the Regulatory team in the daily regulatory activities, as indicated by the Regulatory manager /li liPrepare and maintain UpToDate International data bases (e.g. Eudamed, UDI, etc) /li liSupport during the audit/inspection carried out by Notified Body or Competent Authorities for the facility’s certification /li /ul h3What business skills are we looking for? /h3 ul liTechnical degree /li li1 years in similar position preferably in a Medical Device Company /li liGood English and Italian, both written and oral /li liKnowledge of medical device European MDR. Any additional regulations knowledge, such as U.S. Japanese, Canadian, Latin America, Middle East, India,Asia-Pacific regulations, would be a plus. /li liTechnical knowledge of the medical devices and of the Company manufacturing processes /li /ul h3What soft skills are we looking for? /h3 ul liExcellent organizational skills and multitasking /li liProblem solving /li liWork precisely according to procedures, rules and regulations /li liResult oriented /li liSkill as autonomy, orderliness, attention to detail and deadline /li liAnalytical approach to regulatory issues /li liProject management /li liResponsibility for the assigned tasks /li liAble to work in team and autonomously as well /li liOpen mind to different culture /li liAble to work under pressureAble to work on assigned multitasks /li /ul h3What will you find? /h3 ul liFriendly, warm, and innovative atmosphere /li liHealthy, inspiring, and international and inclusive work environment /li liTraining and development opportunities /li liCompetitive reward packages /li liSocial and company events /li liWellbeing initiatives (welfare) /li liCanteen /li liBenefits (Pension Fund- Health Insurance etc..) /li liWorking Hours: 8:30-17:30 Monday to Thursday and 8:30-16:30 Friday. /li /ul h3What do we offer? /h3 ul limaternity substitution /li liFull time /li liSalary range: 30.000/35.000 Euro annual* /li /ul p*please note that this is a range; the complete salary package will be defined based on the seniority / skills of the person /p #J-18808-Ljbffr

📌 Junior International Regulatory Specialist (Bussolengo)
🏢 Orthofix
📍 Bussolengo