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...
all activities comply with SOPs and regulatory requirements.
Perform
Source Document Verification (SDV)
, review ICFs, oversee eCRF completion, and ensure SAE reporting accuracy.
Collaborate with investigators to ensure adherence to
protocols, regulatory...
and reporting
Key Soft Skills
• Strong organizational and time management
• Proactive and solution-oriented mindset
• Excellent communication and negotiation abilities
• Attention to regulatory and documentation detail
What We Offer
• Competitive salary...
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...
power generation facilities. This role is responsible for maximizing revenue delivery, coordinating real-time responses to alarm conditions, and ensuring compliance with all regulatory and contractual obligations.
Key Responsibilities
• Monitor...
and Clinical Affairs
• Report directly to the President, providing regular updates on performance and market trends
Requirements
• Minimum 10 years of experience in sales, with at least 5 in a leadership role
• Proven ability to manage and develop high...
adequately trained in identifying and reporting AEs/SAEs
• Checks that all submissions, reports, notifications and applications to the IEC/IRB or Regulatory Authorities have been made by the Investigator in a timely manner
• Performs drug accountability...
a shared Internal Audit function which operates across the Operating Segments (countries).
Purpose of the Role:
This role will be with the Ardonagh Europe central platform. It will report the Chair of Ardonagh Europe’s Risk and Audit Committee, reporting...
Identify potential risks (technical, regulatory, commercial, or scheduling) and recommend mitigation measures.
• Report on project progress, ensuring clear communication and efficient problem resolution with all stakeholders.
• Contribute to process...
to establish a shared Internal Audit function which operates across the Operating Segments (countries).
Purpose of the Role:
This role will be with the Ardonagh Europe central platform. It will report the Chair of Ardonagh Europe’s Risk and Audit...
Depending on the role, you will improve your business skills (regulatory gap-analysis, process engineering, Project Management, etc.) or technical skills (Big Data, Artificial Intelligence, etc.).
We offer corporate welfare plans, incentive programs with...
at industry events, conferences, and customer meetings.
• Collaborate with cross-functional teams to ensure timely and quality product launches.
• Track regulatory compliance, quality standards, and certifications relevant to the BLE portfolio.
What...
will report to the Head of the Legal and Regulatory Department and will primarily provide support for the following activities:
1. Constant monitoring of the national and European regulatory evolution;
2. Drafting/updating regulations for markets...
and precision to keep customer satisfaction high.
Drive service optimization, improving response times, parts usage, and cost-efficiency.
Track and report service KPIs to ensure continuous improvement.
Pre-Sales Support
Collaborate with the sales team to provide...
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...