15 ott - Leivi
Orthofix
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 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. 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.
Responsibilities include collaboration with all internal departments, consultants, subsidiaries, distributors, external laboratories and suppliers for successful regulatory activities in each impacted area. Assures,
that the Regulatory International documentation on paper or on electronic relevant to a new or modified products is adequately updated for International Products applications. Provide in timely manner any regulatory product registration/submission information status to able to update the Regulatory file platform /data on time.
Prepare and maintain UpToDate International data bases ( Eudamed, UDI, etc) Support during the audit/inspection carried out by Notified Body or Competent Authorities for the facility's certification What business skills are we looking for? Technical degree 1 years in similar position preferably in a Medical Device Company Good English and Italian, both written and oral Knowledge of medical device European MDR. Any additional regulations knowledge, such as Japanese, Canadian, Latin America, Middle East, India,Asia-Pacific regulations, would be a plus.
Technical knowledge of the medical devices and of the Company manufacturing processes Project management Able to work in team and autonomously as well Open mind to different culture Friendly, warm, and innovative atmosphere Healthy, inspiring, and international and inclusive work environment Training and development opportunities Wellbeing initiatives (welfare) Benefits (Pension Fund- Health Insurance etc..) Working Hours: 8:30-17:30 Monday to Thursday and 8:30-16:30 Friday.
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