QA&RA Manager

QA&RA Manager

A medical device startup company in Tel-Aviv focused on minimally invasive surgical solutions is looking for an experienced QA/RA Manager to join our team. The ideal candidate will have the overall responsibility for directing and executing the company's regulatory strategy and quality assurance activities.

 Key Responsibilities:

1. Oversight and management of all aspects of quality assurance and regulatory compliance activities.
2. Regulatory strategy execution for product approvals and market clearances.
3. Management of regulatory submissions (e.g., 510(k), DENOVO, IDE, Technical Files for CE Marking) and communications with FDA, Notified Bodies, and other regulatory authorities.
4. Implementation of quality management systems (QMS) to ensure compliance with FDA and international regulations.
5. Working with R&D team on design control activities throughout the product development lifecycle in compliance with 21 CFR 820.30, ISO 13485, and MDR requirements. Ensuring proper documentation, verification, validation, risk management, and design reviews during product development.
6. Managing the Design History File (DHF) to ensure regulatory compliance.
7. Leadership in design transfer activities, ensuring smooth transition from R&D to manufacturing while maintaining compliance with regulatory and quality standards.
8. Collaboration with engineering and manufacturing subcontractor to ensure process validation and production readiness.

 Qualification and Requirements:

• Bachelor’s degree in Biomedical Engineering, or a related field (Master's or MBA advantage).
• Minimum of 4 years of experience in Quality Assurance and Regulatory Affairs within the medical device industry.
• Strong English proficiency (spoken and written).
• Ability to manage multiple projects simultaneously and thrive in a fast-paced and dynamic environment.

To apply, please send your CV to: [email protected]