Regulatory affairs specialist junior

4 settimane fa

Rome, Italia Cosmo Intelligent Medical Devices A tempo pieno

Cosmo IMD is a division of the Cosmo Pharmaceutical group focusing on medical devices integrating artificial intelligence. Cosmo IMD has developed in recent years unrivaled expertise in multiple aspects related to the AI Med Tech business, such as medical device Hardware and Software design, healthcare Artificial Intelligence development, medical data harvesting, clinical development, scientific production, and regulatory expertise in the US and worldwide. Cosmo IMD team is manufacturing GI Genius, the world’s first real-time artificial intelligence medical device that is globally distributed by Medtronic.About the roleMember of the Regulatory Affairs department cooperating in regulatory submissions and registrations, periodic reports, communications with internal and external stakeholders, and interacting with other departments to the compliant management of medical device lifecycle according to applicable regulations, jurisdictions, guidance and standards. Key Responsibilities:Assess, prepare, and manage technical documentation to support certification and submission processes in the European Union and U. S. A. Prepare and manage technical dossiers for submission in other countries according to local regulations and guidance documents. Cooperate with other departments to the creation and update of technical documentation needed according to country requirements. Assist external stakeholders in the regulatory process per country requirements.Maintain and update certifications, registrations, and renewals as required by country regulations and assess regulatory impact of medical device changes with respect to country requirements.Cooperate to the management of documented material and communications with Competent Authorities, Certification Bodies, and other stakeholders according to the given regulatory aspect.Cooperate to the management of company regulatory procedures by timely awareness and implementation of changes due to the development in the regulatory landscape. Assist in internal and external audits and provide regulatory input to optimize company compliance and minimize the possibility of non-compliance findings.Promote the culture of compliance by proactively interacting with all departments and by provision of trainings.Cooperate to the development of new activities, adapt to new challenges and opportunities, and take on new duties stemming from the development path of company activities.Qualification – Skills, and AbilitiesEducationBachelor’s degree in engineering, science or related scientific discipline, or equivalent. Higher degree/Ph D will be an advantage.ExperienceMinimum of 2 years of experience in regulatory affairs roles within the medical devices or healthcare industry.SkillsEnglish proficiency at professional levelProfessional knowledge of Reg. (EU) 2017/745 and Title 21 CFR parts 800-898 and technical standards ISO 13485, ISO 14971.Practical understanding of scientific and technological aspects related to software, computer engineering, artificial intelligence, and endoscopy.Personal Attributes:Strong analytical skills with a detail-oriented approach.Ability to work independently and collaboratively across multifunctional teams.Highly dynamic and adaptable to a fast-moving and innovative environment.Equal Opportunity Statement:The research complies with Legislative Decree 198/2006

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