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Project manager - medical devices compliance

Ne
Alchimia Srl
Pubblicato il 28 gennaio
Descrizione

Ph3Mission Overview /h3pWe are seeking an experienced Temporary Project Manager to lead, on a day-to-day basis, the definition, execution, and monitoring of a comprehensive regulatory compliance action plan for EU Class II and Class III medical device technical documentation. /ppOperating in a high-pressure and time-critical environment, the Project Manager will play a pivotal role in ensuring full alignment with applicable international medical device regulations, while coordinating and mobilizing all relevant internal and external stakeholders. /ph3Key Responsibilities /h3ulliDrive the daily planning, coordination, and execution of the medical device technical documentation compliance action plan. /liliEnsure timely progress, clear prioritization, and rigorous follow-up against defined objectives and regulatory deadlines. /liliAct as the central point of coordination across multidisciplinary teams (Regulatory Affairs, RD, Quality, Clinical, Manufacturing, External Partners, etc.). /liliEstablish strong cross-functional collaboration and foster a culture of accountability and results. /liliAnticipate risks, manage escalations, and implement corrective actions as required. /liliProvide clear, structured, and transparent reporting on progress, issues, and mitigation plans to local management and Group Top Management. /liliEnsure alignment with applicable European and international regulatory frameworks for medical devices. /li /ulh3Operating Context /h3pThis role is set within a demanding environment characterized by regulatory urgency and the need for intense cross-departmental cooperation. Success requires strong leadership, decisiveness, and the ability to align diverse stakeholders toward unambiguous objectives and fixed timelines. /ppThe Project Manager will have full legitimacy, authority, and active support from both local management and Group Top Management to successfully deliver the mission. /ph3Candidate Profile /h3pThe successful candidate will demonstrate the following mandatory qualifications and attributes : /pulliProven and formal training in project management methodologies (mandatory). /liliDemonstrated experience and solid knowledge of medical devices and relevant international regulations (EU MDR and related frameworks). /liliFluency in Italian is required; proficiency in English is necessary for communication with the holding group. /liliStrong leadership and facilitation skills, with the ability to federate teams around common objectives. /liliNatural authority, credibility, and the capacity to drive decisions in complex and pressured environments. /liliExcellent communication, organizational, and stakeholder management skills. /li /ulh3Why Join This Mission /h3pThis assignment offers a high-impact opportunity to play a critical role in a strategic regulatory compliance initiative, with strong executive sponsorship and decision-making authority, in a context where results, leadership, and execution excellence are paramount. /ppThis job posting is open to candidates of all genders, in compliance with applicable laws (L. 903 / 77 and L. 125 / 91). /p /p #J-18808-Ljbffr

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