תיאור תפקיד:
A medical technology startup developing and commercializing AI-powered Software as a Medical Device (SaMD) is looking for a hands-on QA/RA Manager.
This is an individual contributor role, responsible for maintaining quality management systems, ensuring regulatory compliance, and supporting software development processes in a regulated medical environment.
Responsibilities:
• Manage and maintain the company's Quality Management System (QMS), ensuring compliance with applicable FDA and ISO standards.
• Oversee quality processes throughout the Software Development Life Cycle (SDLC), including software verification and validation.
• Manage quality documentation, change control processes, CAPA, and risk management activities.
• Conduct internal audits and coordinate external regulatory and certification audits.
• Support regulatory compliance activities and submissions, including FDA requirements.
דרישות:
• 3-5 years of experience in Quality Assurance and Regulatory Affairs within the medical device industry, preferably with SaMD.
• Proven hands-on experience managing QMS in accordance with ISO 13485, FDA QMSR, and ISO 14971.
• Strong knowledge of IEC 62304 and medical software development processes (SDLC).
• Experience conducting internal audits and managing external audits.
• Hands-on experience using AI tools such as Claude, ChatGPT, and similar platforms in daily workflows - a must.
היקף משרה:
משרה מלאה
קוד משרה:
JB-5610
אזור:
מרכז - תל אביב, פתח תקווה, רמת גן וגבעתיים, בקעת אונו וגבעת שמואל, חולון ובת-ים, מודיעין, שוהם
שרון - חדרה וזכרון יעקב, נתניה ועמק חפר, רעננה, כפר סבא והוד השרון, ראש העין, הרצליה ורמת השרון
השפלה - ראשון לציון ונס- ציונה, רמלה לוד, רחובות, יבנה
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