QA / RA Director

Tel Aviv, Israel
Full-time

Position Summary

Notal Vision is developing medical devices for home monitoring of eye diseases, including a visual-field testing device, an Optical Coherence Tomography (OCT) device for retinal imaging and a proprietary, first of its kind, machine-learning based automated interpretation of retinal OCT imaging.

Specific Duties

• Review, update and maintain the Quality Manual of the Notal Vision’s Israel including R&D, engineering and manufacturing and US operation including sales, distribution, repairs and customer support
  
• Review and update all the company’s SOP with a primary objective of meeting the FDA requirements
• Prepare and validate the company’s readiness to an FDA and ISO audits
• Interface with external regulatory consultants
• Direct the ongoing QA aspects of the R&D, engineering and manufacturing activities
• Direct the ongoing QA activities as they relate to handling products and communication with consumers and practices, including customer feedback, analysis of CRM records, customer’s complaint, adverse events, HIPPA compliance, privacy issues etc.
• Review and update the regulatory documentation related to the 510(k), CE, AM”AR and any future territories
• Coordinate and lead the regulatory path of the company’s products

Requirements

• 5+ years’ experience of Quality Assurance and Regulatory Affairs of consumer medical devices
• Thorough knowledge of cGMP requirements
• Strong understanding of regulatory requirements for commercial products
• Proven track record with FDA, EMEA and other Health Authorities.
• Strong understanding of risk assessment and risk management fundamentals/tools
• Team and consensus builder
• Ability to communicate effectively in English (both written and oral)
• Demonstrated experience and proficiency with MS Office

To apply, email cover letter and CV to HR@notalvision.com