dettagli offerta pubblicato giovedì 18 marzo 2021 luogo di lavoro pomezia, lazio categoria Ingegneria sottocategoria Biomedico tipo di contratto somministrazione riferimento CX147348 offerta proposta da elena.rocca@randstad.it Candidati ora > Invia offerta via email stampa descrizione For a multinational company in the chemical-pharmaceutical field, we are looking for a Biomedical Engineer who will manage the European regulatory activity, ensuring compliance, carrying out research with clinical studies and identifying data gaps in medical devices. responsabilità Main tasks:Medical input for technical file and other documents for Regulatory and Quality groups in support of MDR Cadence execution;Research, prepare and document responses to Medical Informations Requests (MIR);Review medical content in Copy Approval process, consulting with Franchise Medical Director, when needed, in support of MDR Cadence Execution;Input to cross functional team with respect to evidence assessment, literature review, analysis and conclusion for Clinical Evaluation Report per MDR Cadence Execution;Review and input for risk management documents and product labeling for MDR Cadence Execution; competenze Main features required:General knowledge of surgery and surgical conditions;Experience in scientific literature review, analysis and conclusions;Fluency in English both written and spoken, other EMEA languages are a plus;Excellent presentation skills;Extended experience in using IT tools, including Microsoft Office;A current license to practice Medicine and board certification in a surgical specialty are preferred;Previous exposure to MDR activities would be a plus.We offer a 1-year part-time contract with the possibility of both personal and professional growth, with a contractual level to be defined based on the candidate's real skills. Work area: Pomezia (RM) livello di studio Laurea specialistica o a ciclo unico I candidati ambosessi (L.903/77) sono invitati a leggere l’informativa sulla privacy ai sensi dell'art. 13 del Regolamento (UE) 2016/679 sulla protezione dei dati (GDPR).