CONTEXT:The Quality Management System and Regulatory Affairs Manager is responsible for ensuring the compliance of the quality management system with ISo 13485, ISO 9001 and regulatory requirements; developing along the way our strategy to continuously improve our results, inside our regulatory frame with an overall global accountability for all Quality and Regulatory related topic in Italy and Menarini Diagnostics subsidiaries.MAIN ACTIVITIES AND RESPONSIBILITIES:• Build, Define, Direct, and Monitor all related Quality and Regulatory Know-how, processes, best practices, and KPIs.• Design and develop processes of global projects and support the QA & R activities in the EU/FDA environment (in particular about the definition of product requirements, risk management and assessment of the regulatory impact of the changes made to the product, identification of applicable standards and also in the preparation and review of product verification and validation plans)• Perform other general duties as required to support other departments of the company: Information Systems and Technology, Data Management, Biostatistics, Clinical Operations, Medical Safety, and Business Development. QUALITY• Interact closely with the CEO to meet internal Quality Assurance (QA) objectives and timelines.Function will include planning of Quality strategies in close association with company goals and needs.• Implement a QA program by Company Policy• Manage the QA team to ensure that all the activities related to Quality Management System, induding document approval, release and post-marketing activities, are correctly and timely performed• Ensure that other personnel involved in QA activities are qualified and trained as needed to perform this function• Strive for continual improvement of QA processes, activities, and results.REGULATORY• Interpret regulatory requirements, develop strategies (including novel approaches), assess risks, and develop contingency proposals• Coordinate the team to manage documentation of the Regulatory files to maintain quality assurance consistent with FDA, Worldwide Regulatory Authorities, and other appropriate regulations.• Ensure all regulatory activities are executed effectively and efficiently and in compliance with external regulatory requirements & internal quality procedures• Use technical and scientific knowledge to coordinate the team in the preparation and analysis of global submission documentation and the maintenance of product compliance and management of change control• Serve as a liaison with regulatory agencies for specific topics providing oversight for the fulfillment of agency commitments and providing responses to agency queries• Coordinate the team to maintain an accurate and useful database of pertinent Regulatory information.Interpret and process regulatory information for use as needed to perform the function• Develop and maintain Regulatory policies and procedures (Standard Operating Procedures, Protocol Specific Procedures, training manuals). Requisitos QUALIFICATIONS & REQUIREMENTS:• Scientific / Technical Degree• At least 5 years of experience in a similar role within the Medical Device/VD sector is a mandatory requirement• Excellent knowledge of Quality Management System standards (ISO 13485, ISO 9001)• Excellent knowledge of Regulation EU 2017/746 on In Vitro Diagnostic Medical Devices• Knowledge of Regulation EU 2017/745 on medical devices will be a preferential requirement• Experience leading a team with broad skills and functional requirements.• Good computer skills, and an advanced level of knowledge of the Office package• Adaptable to working independently and in multidisciplinary teams, and proficient in leading projects• A personal dedication to a high standard of work and attention to detail• Shows consistent initiative and determination• Excellent organizational skills, planning, communication, and follow-up skills. Se ofrece The process will be managed from the global talent adquisition deparment.
