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...
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...
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...
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...
efficient and sustainable investment strategies, implement investment policies, and ensure compliance with ethical and regulatory criteria. Additionally, conduct market analysis, evaluate new financial instruments, and prepare reports for the Investment...
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...
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...
ensuring adherence to business and regulatory standards.
• Review and update calibration and requalification procedures in coordination with relevant functions.
• Ensure compliance with company quality standards and report any non-compliance.
• Manage the...
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.
Day-to-Day Responsibilities...
Anonymous via Search & Selection International Projects-Roma
plant, ensuring optimal performance, safety, and regulatory compliance.
• You will lead, direct, and motivate a multidisciplinary team across engineering, maintenance, operations, HSE, HR, and supply chain management to achieve the highest levels of...
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...
Coordinate requalification plans for GMP equipment, ensuring adherence to business and regulatory standards.
• Review and update calibration and requalification procedures in coordination with relevant functions.
• Ensure compliance with company quality...
Group dedicata a valorizzare le esperienze, le competenze e il potenziale dei candidati in ambito Sales&Marketing, Clinical Research, Regulatory e Operation dei settori Farmaceutico e Medicale e per le mansioni legate all’assistenza al cliente del mondo...