Biosense Webster

QA&RA Specialist- QARA

Job Description

This is your opportunity to join a leading Medical Company, New Product Development QA&RA Department, support R&D projects, lead and make an impact on product Quality and Health of millions of people globally.

Regulatory activities:
• Accompanying Product Development Process for the New Product (from Feasibility stage to the Transfer to Production stage)
• Developing regulatory strategy for the New Products and performing of the notifications to the NB’s and Health Authorities Worldwide
• Support product certificates renewal and new products registration Worldwide, including TF/TD preparation, 510(k) or Special files submissions.

Quality activities:
• Accompanying Product Development Process for the New Product in accordance with QMS requirements and guidelines (from Feasibility stage to the Transfer to Production stage)
• Preparation and Maintenance of the Product DHF
• Creation of DHF documents, updating QMS procedures, support for Risk Management and Defect Management activities, review, and approval product related documents.

General:
• Preparation and participation in internal and external audits
• Responsibility for products compliance with Global Regulations and Standards
• Work for efficiency and Improvement of the existing process in the company

Qualifications

• Mandatory bachelor’s degree (Engineering is an advantage);
• At least 2.5 years of experience in QA or RA in the field of Medical Devices
• Familiarity with Medical Device Regulations, Quality Processes and Standards: 21 CFR, MDD / MDR, CANADA SOR, ISO 13485, ISO 14971, ISO 9001, IEC 60601-1, IEC 60601-1-2; IEC60601-1-6; IEC62304; ISO 14001; China and Japan regulations
• Experience in accompanying external and internal audits, Internal Auditor Certificate – an advantage
• High level of English- mandatory

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