Head of QA & Regulatory Affairs

ElastiMed is an FDA cleared medical device startup developing next-generation wearable compression therapy solutions powered by proprietary smart materials. Our mission is to enhance quality of life for patients with venous and lymphatic disorders by improving circulation and mobility—through a clinically proven, comfortable, and fully wearable device.

Responsibilities:

Quality Assurance:

·      Maintain and continuously improve ElastiMed’s QMS (ISO 13485:2016)

·      Manage document control, CAPAs, NCRs, audits, and training programs

·      Lead internal and supplier audits; coordinate third-party audits and inspections

·      Oversee validation activities for manufacturing, testing, and software

Regulatory Affairs:

·      Maintain compliance with FDA, CE, and other global regulatory requirements

·      Prepare and manage regulatory submissions (510(k), MDR, PDAC, etc.)

·      Interface with regulatory bodies and notified bodies as needed

·      Monitor changes in regulatory standards and advise on impact

Logistics & Operations:

·      Manage product logistics and documentation to ensure compliant distribution and traceability

·      Coordinate with manufacturing and fulfillment partners to align quality, regulatory, and delivery requirements

·      Support inventory management processes and implement systems for shipping documentation and product traceability

General:

·      Work closely with R&D, Operations, and Clinical teams to ensure quality and regulatory considerations are embedded across all activities

·      Support labeling, risk management, and clinical documentation

Requirements:

·      B.Sc. in related field (M.Sc. a plus)

·      3+ years experience in QA/RA roles within the medical device industry

·      Proven knowledge of ISO 13485 and FDA QSR

·      Hands-on experience with 510(k) submissions or CE marking

·      Excellent written and verbal communication skills in English and Hebrew

·      Strong organizational skills and ability to work independently in a dynamic setting