h3Why Orthofix? /h3pGuided 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 International Regulatory Specialist to join our Regulatory Affairs team, based in Bussolengo (Verona) on a maternity substitution contract. You will report to the Regulatory Affairs Manager. You 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. /ppResponsibilities include collaboration with all internal departments, consultants, subsidiaries, distributors, external laboratories and suppliers for successful regulatory activities in each impacted area. /ph3What will your contribution be? /h3ulliAssures, that the Regulatory International documentation on paper or on electronic relevant to a new or modified products is adequately updated for International Products applications. /liliProvide in timely manner any regulatory product registration/submission information status to able to update the Regulatory file platform /data on time. /liliPrepare and maintain updated Procedure Pack Files. /liliAs needed,



support the Regulatory team in the daily regulatory activities, as indicated by the Regulatory manager /liliPrepare and maintain UpToDate International data bases (e.g. Eudamed, UDI, etc) /liliSupport during the audit/inspection carried out by Notified Body or Competent Authorities for the facility’s certification /li /ulh3What business skills are we looking for? /h3ulliTechnical degree 1 years in similar position preferably in a Medical Device Company /liliGood English and Italian, both written and oral /liliKnowledge of medical device European MDR. /liliAny additional regulations knowledge, such as U.S. Japanese, Canadian, Latin America, Middle East, India,Asia-Pacific regulations, would be a plus. /liliTechnical knowledge of the medical devices and of the Company manufacturing processes /li /ulh3What soft skills are we looking for? /h3ulliExcellent organizational skills and multitasking /liliProblem solving /liliWork precisely according to procedures, rules and regulations /liliResult oriented /liliSkill as autonomy, orderliness, attention to detail and deadline /liliAnalytical approach to regulatory issues /liliProject management /liliResponsibility for the assigned tasks /liliAble to work in team and autonomously as well /liliOpen mind to different culture /liliAble to work under pressure /liliAble to work on assigned multitasks /li /ulh3What will you find? /h3ulliFriendly, warm, and innovative atmosphere /liliHealthy, inspiring,



and international and inclusive work environment /liliTraining and development opportunities /liliCompetitive reward packages /liliSocial and company events /liliWellbeing initiatives (welfare) /liliCanteen Benefits (Pension Fund- Health Insurance etc..) /li /ulh3Working Hours /h3p8:30-17:30 Monday to Thursday and 8:30-16:30 Friday. /ph3What do we offer? /h3ullimaternity substitution /liliFull time /liliSalary range: 30.000/35.000 Euro annual* /lili*please note that this is a range; the complete salary package will be defined based on the seniority / skills of the person /li /ulpSince 1980, Orthofix has evolved and grown to become one of the leading medical device companies with a spine and orthopedics focus in the world. Our newly merged Orthofix-SeaSpine organization is a leading global spine and orthopedics company with a comprehensive portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions, and a leading surgical navigation system. Our products are distributed in 68 countries worldwide. Our medical device company is headquartered in Lewisville, Texas, and has primary offices in Carlsbad, CA, and Verona, Italy. Our combined company’s global RD, commercial and manufacturing footprint also includes facilities and offices in Irvine, CA; Toronto, Canada; Sunnyvale, CA; Wayne, PA; Olive Branch, MS; Maidenhead, UK; Munich, Germany; Paris, France; and São Paulo, Brazil. Founded in Verona, Italy, and now headquartered in Lewisville, Texas, Orthofix is proud to be recognized as the 8th Largest Orthopedic Medical Device Company in the World by Medical Design Outsourcing magazine. Orthofix is committed to improving patients’ lives and delivering innovative, quality-driven solutions that empower physicians and healthcare organizations to meet the needs of their patients every day. /p #J-18808-Ljbffr

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