of 5 years of experience in the regulatory affairs field in medical device industry of which minimum of 2 years of experience in vigilance reporting according to 21 CFR Part 803 in U.S and to MDD/MDR requirements in EU.
Skills
• English proficiency...
Unlocking the full potential of life.
Job Purpose
The position to be covered is in the RA department of Recordati Campoverde site, reporting to the RA Manager. Responsible for regulatory affairs activities to assist in the submission of regulations, annual...
Cosmo Intelligent Medical Devices-Giuliano di Roma
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...
and a strong understanding of regulatory frameworks, permitting, and stakeholder engagement. You will manage projects from concept to construction-ready status, ensuring alignment with company objectives and effective coordination across teams.
Key...
Senior Regulatory Affairs Specialist of Cosmo Intelligent Medical Devices.
Work Location: Rome – Italy – Viale Ostiense 131/L
Key Responsibilities:
• Assess medical device safety by providing input/review to the risk management activities...
will play a critical role in safeguarding the integrity of our operations by ensuring full compliance with regulatory requirements, industry standards, and best practices. You will oversee the implementation and continuous improvement of our compliance...
market, and a strong understanding of regulatory frameworks, permitting, and stakeholder engagement. You will manage projects from concept to construction-ready status, ensuring alignment with company objectives and effective coordination across teams...
candidate will report to the Head of the Legal and Regulatory Department and will primarily be involved in the following activities:
• Continuous monitoring of national and European regulatory developments;
• Drafting/updating regulations for markets...
you will play a critical role in safeguarding the integrity of our operations by ensuring full compliance with regulatory requirements, industry standards, and best practices. You will oversee the implementation and continuous improvement of our...
the company's security program. Your principal job will be working with the 1st Line CyberSecurity team to address risks in the organization, conducting risk assessments regularly and reporting the effectiveness of security controls to the management...
services, aligning project needs with regulatory demands.
Participate actively in the review of environmental documentation related to the relazione di ottemperanza (compliance report) to assess and ensure that all stipulated conditions are met...
workplace health and safety by managing industrial hygiene programs, conducting exposure assessments, and ensuring regulatory compliance. A key part of this role is to support the New Product Introduction (NPI) process, ensuring that safety and hygiene...
regulatory updates, and trends in the areas of focus and promoting best practices
• Working with marketing and HR teams to drive internal engagement and promote storytelling
• Driving annual reporting for shareholders, and annual submission of Ecovadis & UNGC...
the company's security program. Your principal job will be working with the 1st Line CyberSecurity team to address risks in the organization, conducting risk assessments regularly and reporting the effectiveness of security controls to the management...
report to the Campaign Lead for Southern Europe, and you will be part of the multi-skilled campaign team, helping to define, design and implement high-impact strategic policy and partnerships initiatives.
In this role you must be skilled in regulatory...