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Project manager - medical devices compliance

Ponte San Nicolò
Alchimia srl
Pubblicato il Pubblicato 22h fa
Descrizione

PstrongAlchimia /strong is one of the leading European manufacturers of medical devices for ophthalmic surgery and tissue banks. With our expertise in the fields of chemistry, microbiology, and pharmacology, at Alchimia we have adopted this rule: we design each medical device as if it were intended for ourselves. /ppSince our foundation in 1993, all our products have been developed in collaboration with opinion leaders and the scientific community before being released to the market. This allows us to offer safe, useful, and effective solutions to improve the daily operations of medical staff and the quality of life of their patients. Our commitment to research makes us a reliable partner, able to provide ongoing training and updated scientific information to our distributors and product users. Thanks to the Alchimia team, we now have a network of over 60 independent distributors across Europe and the world, capable of providing fast local service to all our customers. /ppbr/ppTo expand our team, we are looking for a strongTemporary Project Manager – Medical Devices Compliance /strong. /ppbr/ppstrongMission Overview /strong /ppbr/ppWe are seeking an experienced strongTemporary Project Manager /strong 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. /ppbr/ppstrongKey Responsibilities /strong /ppbr/pullistrongDrive /strong the daily planning, coordination, and execution of the medical device technical documentation compliance action plan. /lilistrongEnsure /strong timely progress, clear prioritization, and rigorous follow-up against defined objectives and regulatory deadlines. /lilistrongAct /strong as the central point of coordination across multidisciplinary teams (Regulatory Affairs, RD, Quality, Clinical, Manufacturing, External Partners, etc.). /lilistrongEstablish /strong strong cross-functional collaboration and foster a culture of accountability and results. /lilistrongAnticipate /strong risks, strongmanage /strong escalations, andstrong implement /strong corrective actions as required. /lilistrongProvide /strongclear, structured, and transparent reporting on progress, issues, and mitigation plans to local management and Group Top Management. /lilistrongEnsure /strong alignment with applicable European and international regulatory frameworks for medical devices. /li /ulpbr/ppstrongOperating Context /strong /ppbr/ppThis 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. /ppbr/ppstrongCandidate Profile /strong /ppbr/ppThe successful candidate will demonstrate the following mandatory qualifications and attributes: /pullistrongProven /strong and strongformal training /strong in project management methodologies (mandatory). /liliDemonstrated experience and strongsolid knowledge of medical devices /strong and relevant international regulations (EU MDR and related frameworks). /lilistrongFluency in Italian /strong is required; strongproficiency in English /strong is necessary for communication with the holding group. /lilistrongStrong leadership /strong and facilitation skills, with the ability to federate teams around common objectives. /liliNatural authority, credibility, and the strongcapacity to drive decisions /strong in complex and pressured environments. /lilistrongExcellent communication /strong, organizational, and stakeholder management skills. /li /ulpbr/ppstrongWhy Join This Mission /strong /ppbr/ppThis 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. /ppbr/ppThis job posting is open to candidates of all genders, in compliance with applicable laws (L. 903/77 and L. 125/91). /p

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