Rc and QA Specialist

2 mesi fa


Roma, Italia Abbott Laboratories A tempo pieno

Follow company policies and procedures and operating guidelines conforming to Abbott quality

requirement, law and regulations.

**Key Responsibilities**
- Support commercial operations regarding all local affiliate regulatory compliance and quality

system matters to affiliate operations, Europe/Regional Headquarters and the Manufacturing

Business Units
- Perform timely Product Experience Handling and Vigilance Reporting (for Italy and Iberia)
- Support the affiliate for appropriate handling of Field Safety Notice and Field Safety Corrective

Actions
- Support the tender department for regulatory compliance documents and quality system

information
- Provide support on local regulations and quality system by reviewing procedures, performing

training, receiving assessments and audit, etc.

**Education Required**

5 years university degree or 3+ years of experience in regulatory in a medical device company/

**Skills and experience**

Good knowledge of English (listening and writing)

Quality Management - Regulatory legislation and guidelines for Medical Device applicable in a

commercial organization (e.g. post marketing surveillance)

Critical thinking, Attention to details, Time-management attitude, Empathy.


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