Junior QARA Consultant Medical Device

Updated: April 11, 2024 11:28 AM GMT

TSQuality

Riccione, Province of Rimini

Position Description and Responsibilities:

Supporting our clients and internal team in International Regulatory and Quality activities for Medical Devices and Combination products including:
• MDR 2017/745 Transition support
• QMS Compliance
• PMS
• Usability documentation
• Design History File
• Risk Management
• Clinical Evaluation
• Documentation drafting and authoring

Requirements:
• Degree in Biomedical Engineering or similar
• 2 year of experience in medical device QARA
• High attention on documentation drafting
• Open mind and multitask attitude
• Able to work under the coordination and deliver on the task as well as lead and organize alone
• Good communication with internal and external stakeholders
• Positive attitude and passion for regulatory work

Language:

Must: Italian and English

Good to have: German or French

Offered:
• Onboarding MDR and QARA Training package including ISO 13485:2016 Internal and Supplier Auditor course
• Flexible set-up remote/onsite
•... More Detail