Obelis European Authorized Representative Center
"CE Marking Consultants with a Reputation for Excellence"Sandra Ferretti
With over 10 years experience in quality assurance and EU regulations, the C.C.O. is responsible for overseeing and managing compliance issues within the organization and ensuring internal and client compliancy.
The responsibilities of the position include leading enterprise compliance efforts, designing and implementing internal controls, policies and procedures to assure compliance with applicable local laws, Member States, EU laws, EU regulations and third party guidelines, managing audits and investigations into regulatory and compliance issues, and responding to regulatory requests for information from clients and regulatory bodies.
Notification & registration department
- MDD Class I notifications
- Clinical Investigation Notification
- Other Device registrations in EU Member States
- Cosmetic products notifications
- Other notifications
- Free sales certificates
- Trade mark registration
ISO Quality Management System
- Internal auditing
- Documents and procedures QA and management
Regulatory department
- Classification issues
- Regulatory researches and compliance
- Human resource compliance and administration compliance
- Education programs
International Markets
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