Junior Regulatory Product Maintenance specialist

ph3Why 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 Regulatory Product Maintenance specialist /b to join our bRegulatory Affairs /b team, based in Bussolengo (Verona) on a temporary contract of 1 year. You will report to the bRegulatory Affairs Manager. /b /p pYou 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. /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 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. /li liMaintain 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 planned deadline, as indicated by Regulatory Affairs manager and/or RA team. /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 Product technical sheet in Italian and English version. /li liInterface with Notified body for the update of the Technical Documentation Files maintenance. /li liSupporting the International registrations documentation’ requests. /li liSupporting for the Products leaflets/IFU and labeling maintenance. /li liCollaborate for any changes to Product impacting the regulatory documents. /li liTravel 10%. /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 pressure /li liAble 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 li1 year temporary contract /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 h3DISCLAIMER /h3 pThe duties listed above are intended only as representation of the essential functions of this position. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer. Nothing in this document alters an employee’s at-will employment status. /p pWe are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, caste, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, or any other protected status in accordance with all applicable federal, state, and local laws. /p pThis policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment. /p /p #J-18808-Ljbffr