REGULATORY AFFAIRS OFFICER
Περιγραφή εργασίας
*Update the QMS
*Update Technical Dossier for the CE marked products of the company
*Internal audits
*External audits to factories
*Registration and renewals of Products worldwide
*Prepare Authorization (F-240) / Distribution Agreements (F-023)
*Keep update the form F-024 Distribution List
*Prepare Supplier Agreement (F-039)
*Update the D-012 Supplier Control List / Supplier / Subcontractor
*Tender Documents and support to Sales Team
*Keep Employees File, verification of employees records continuous professional development)
*Maintain update the D-012 Supplier Control List / Supplier / Subcontractor
*Prepare PMS / PSUR and PMCF
*Update the F-007 - LIST OF HARMONIZED STANDARDS AND REGULATIONS FOR MEDICAL DEVICES
REQUIRED SKILLS
*CONSCIENTIOUS AND RESPONSIBLE
*A KEEN EYE FOR DETAIL AND A RESULT-DRIVEN APPROACH
*OUTSTANDING COMMUNICATION SKILLS
*EXCELLENT ORGANIZATIONAL AND LEADERSHIP SKILLS
*PROFICIENT IN MS OFFICE
*IN DEPTH UNDERSTANDING OF QUALITY CONTROL PROCEDURES AND RELEVANT LEGAL STANDARDS
*EXCELLENT KNOWLEDGE OF ENGLISH
*AT LEAST BSc in PHARMACY, PHARMACEUTICAL INDUSTRY, BIOCHEMISTRY, CHEMICAL ENGINEERING OR RELATED FIELD
*CERTIFICATION OF QUALITY CONTROL IS A STRONG ADVANTAGE (ISO9000, 13485 etc)
Πώς να υποβάλετε αίτηση
Please send your CV to email
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