Rc and QA Specialist - Roma, Italia - Abbott Laboratories
Descrizione
Follow company policies and procedures and operating guidelines conforming to Abbott qualityrequirement, law and regulations.
Key Responsibilities
- Support commercial operations regarding all local affiliate regulatory compliance and quality
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
- Support the tender department for regulatory compliance documents and quality system
- Provide support on local regulations and quality system by reviewing procedures, performing
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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