RA/QA Professional

A high caliber Regulatory and Quality specialist; who has a minimum of 3 years of expertise in QMS and Regulatory of medical devices, is going to be hired as a consultant.
The candidate should be ready to deal with many projects at the same time under project deadlines.

• Graduated from a life science or an engineering department of a reputable university. 
• Minimum 3 years of experience in the production of a medical devices or similar sectors.
• Proven experience in  EN ISO 13485:2016 standard and 93/42/EEC Medical Device Directive
• Deep knowledge of Process Validations 
• Deep knowledge of 2017/745/EC Medical Device Regulation, 
• Excellent time management ability and able to work in tight timescales
• Self-motivated, able to work alone, able to work remotely
• Proficiency in MS Office applications
• Knowledge of Statistics, Software validation, or ISO 60601 series standards are pluses.
• An international mindset and excellent communication skills in English
• The ability and track record of working effectively with domestic and international customers.