QA/RA Manager

QA/RA Manager

Location: Petach Tikva, Israel

Position Type: Part-Time

About the Role

We are seeking an experienced part-time QA/RA Manager to build and lead our Quality Assurance

and Regulatory Affairs functions. You will be responsible for establishing and maintaining a

robust Quality Management System (QMS) in compliance with ISO 13485, EU MDR, and

FDA requirements. This is a critical role as we scale our in-house manufacturing operations

and expand into new markets.

Key Responsibilities

Quality Assurance & Processes

• Develop and implement QMS procedures aligned with ISO 13485 and applicable regulations.
• Establish and optimize QA processes for our expanding in-house assembly line operations.
• Maintain critical quality documentation including design history files, device master records, risk assessments, and traceability matrices.
• Lead internal audits, manage CAPA processes, and support preparation for external audits (Notified Body, FDA).

Regulatory & Compliance Management

• Ensure all company procedures and technical documentation comply with EU MDR, FDA, and relevant global standards.
• Manage Engineering Change Order (ECO) processes in accordance with ISO 13485 requirements.
• Support product registration and listing in new target markets.
• Stay current on regulatory changes and drive timely implementation across the organization.

Document Control

• Oversee document control systems to ensure all procedures and records meet ISO standards and regulatory requirements.
• Drive quality culture and compliance awareness across the organization.
• Support management review meetings with data-driven quality metrics.

Qualifications

• Education: Bachelor's degree in Engineering, Life Sciences, Quality Assurance, or related field.
• Experience: Minimum 5 years in QA/RA within the medical device industry, with proven expertise in ISO 13485, MDR, and FDA compliance.
• Technical Skills: Hands-on experience with ECO management, document control, CAPA processes, risk management, and audit preparation.
• Audit Experience: Demonstrated ability to lead internal audits and support external regulatory audits.
• Strong communication skills, attention to detail, and ability to work cross-functionally with Engineering, Manufacturing, and Regulatory teams.