Junior International Regulatory Specialist
h3Why Orthofix? /h3 /brpGuided 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 /brpOur 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 /brpWe 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 /brpYou 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 /brpResponsibilities include collaboration with all internal departments, consultants, subsidiaries, distributors, external laboratories and suppliers for successful regulatory activities in each impacted area. /p /brh3What will your contribution be? /h3 /brul /brliAssure,
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 /brliProvide in timely manner any regulatory product registration/submission information status to able to update the Regulatory file platform /data on time. /li /brliPrepare and maintain updated Procedure Pack Files. /li /brliAs needed, support the Regulatory team in the daily regulatory activities, as indicated by the Regulatory manager /li /brliPrepare and maintain UpToDate International data bases (e.g. Eudamed, UDI, etc) /li /brliSupport during the audit/inspection carried out by Notified Body or Competent Authorities for the facility’s certification /li /br /ul /brh3What business skills are we looking for? /h3 /brul /brliTechnical degree /li /brli1 years in similar position preferably in a Medical Device Company /li /brliGood English and Italian, both written and oral /li /brliKnowledge 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 /brliTechnical knowledge of the medical devices and of the Company manufacturing processes /li /br /ul /brh3What soft skills are we looking for? /h3 /brul /brliExcellent organizational skills and multitasking /li /brliProblem solving /li /brliWork precisely according to procedures, rules and regulations /li /brliResult oriented /li /brliSkill as autonomy, orderliness, attention to detail and deadline /li /brliAnalytical approach to regulatory issues /li /brliProject management /li /brliResponsibility for the assigned tasks /li /brliAble to work in team and autonomously as well /li /brliOpen mind to different culture /li /brliAble to work under pressure /li /brliAble to work on assigned multitasks /li /br /ul /brh3What will you find? /h3 /brul /brliFriendly, warm, and innovative atmosphere /li /brliHealthy, inspiring, and international and inclusive work environment /li /brliTraining and development opportunities /li /brliCompetitive reward packages /li /brliSocial and company events /li /brliWellbeing initiatives (welfare) /li /brliCanteen /li /brliBenefits (Pension Fund- Health Insurance etc..) /li /brliWorking Hours: 8:30-17:30 Monday to Thursday and 8:30-16:30 Friday. /li /br /ul /brh3What do we offer? /h3 /brul /brlimaternity substitution /li /brliFull time /li /brliSalary range: 30.000/35.000 Euro annual* /li /br /ul /brp*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
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 /brliProvide in timely manner any regulatory product registration/submission information status to able to update the Regulatory file platform /data on time. /li /brliPrepare and maintain updated Procedure Pack Files. /li /brliAs needed, support the Regulatory team in the daily regulatory activities, as indicated by the Regulatory manager /li /brliPrepare and maintain UpToDate International data bases (e.g. Eudamed, UDI, etc) /li /brliSupport during the audit/inspection carried out by Notified Body or Competent Authorities for the facility’s certification /li /br /ul /brh3What business skills are we looking for? /h3 /brul /brliTechnical degree /li /brli1 years in similar position preferably in a Medical Device Company /li /brliGood English and Italian, both written and oral /li /brliKnowledge 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 /brliTechnical knowledge of the medical devices and of the Company manufacturing processes /li /br /ul /brh3What soft skills are we looking for? /h3 /brul /brliExcellent organizational skills and multitasking /li /brliProblem solving /li /brliWork precisely according to procedures, rules and regulations /li /brliResult oriented /li /brliSkill as autonomy, orderliness, attention to detail and deadline /li /brliAnalytical approach to regulatory issues /li /brliProject management /li /brliResponsibility for the assigned tasks /li /brliAble to work in team and autonomously as well /li /brliOpen mind to different culture /li /brliAble to work under pressure /li /brliAble to work on assigned multitasks /li /br /ul /brh3What will you find? /h3 /brul /brliFriendly, warm, and innovative atmosphere /li /brliHealthy, inspiring, and international and inclusive work environment /li /brliTraining and development opportunities /li /brliCompetitive reward packages /li /brliSocial and company events /li /brliWellbeing initiatives (welfare) /li /brliCanteen /li /brliBenefits (Pension Fund- Health Insurance etc..) /li /brliWorking Hours: 8:30-17:30 Monday to Thursday and 8:30-16:30 Friday. /li /br /ul /brh3What do we offer? /h3 /brul /brlimaternity substitution /li /brliFull time /li /brliSalary range: 30.000/35.000 Euro annual* /li /br /ul /brp*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