Project Manager - Medical Devices Compliance

Alchimia Srl; Lazio; In loco; EUR 50.000 - 75.000; Tempo pieno

Descrizione del lavoro

A leading medical devices company in Italy seeks a Temporary Project Manager specializing in regulatory compliance for EU medical devices. This role involves planning, executing, and monitoring compliance efforts within a high-pressure environment. Candidates should have project management training, experience with medical device regulations, and fluency in Italian. Strong leadership and communication capabilities are essential. Join us to make a significant impact in ensuring compliance and improving healthcare solutions.

Competenze

• Proven formal training in project management methodologies is mandatory.
• Experience with EU MDR and related frameworks is required.
• Fluency in Italian and proficiency in English.

Mansioni

• Drive planning and execution of compliance action plan.
• Ensure timely progress and regulatory deadlines adherence.
• Foster cross-functional collaboration and accountability.
• Manage risks and implement corrective actions as needed.
• Provide structured reporting on compliance progress.

Conoscenze

Project management methodologies

Knowledge of medical devices

Leadership skills

Communication skills

Stakeholder management

Descrizione del lavoro

Overview

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.

Since 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.

To expand our team, we are looking for a Temporary Project Manager – Medical Devices Compliance.

Mission

We 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. Operating 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.

Responsibilities

• Drive the daily planning, coordination, and execution of the medical device technical documentation compliance action plan.
• Ensure timely progress, clear prioritization, and rigorous follow-up against defined objectives and regulatory deadlines, as the central point of coordination across multidisciplinary teams (Regulatory Affairs, R&D, Quality, Clinical, Manufacturing, External Partners, etc.).
• Foster strong cross-functional collaboration and a culture of accountability and results.
• Manage risks, escalations, and implement corrective actions as required.
• Provide clear, structured, and transparent reporting on progress, issues, and mitigation plans to local management and Group Top Management.
• Ensure alignment with applicable European and international regulatory frameworks for medical devices.

Candidate Profile and Qualifications

• Proven formal training in project management methodologies (mandatory).
• Demonstrated experience and solid knowledge of medical devices and relevant international regulations (EU MDR and related frameworks).
• Fluency in Italian is required; proficiency in English is necessary for communication with the holding group.
• Strong leadership and facilitation skills, with the ability to federate teams around common objectives.
• Natural authority, credibility, and the capacity to drive decisions in complex and pressured environments.
• Excellent communication, organizational, and stakeholder management skills.

Context and Why Join

This role operates in 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. The Project Manager will have full legitimacy, authority, and active support from both local management and Group Top Management to successfully deliver the mission.

Location

Rome, Italy

Notes

This job posting is open to candidates of all genders, in compliance with applicable laws (L. 903 / 77 and L. 125 / 91).