QA / RA Associate
Tel Aviv, Israel
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.
Handling of quality functions in combination with regulatory affairs responsibilities in a hybrid role. Support efforts to build and maintain aspects of the quality assurance and regulatory roadmaps. (S)he will provide support in Quality Assurance and Regulatory Affairs activities such as, but not limited to:
- Support the ongoing QA aspects of the R&D, engineering and manufacturing activities.
- Update SOPs, work instructions and other documentation as needed
- Maintaining the ISO 13485 quality system with the 21 CFR 820 QSR, including supplier qualification, documentation control, change control, design controls, complaint handling, non-conforming products, CAPA, etc.
- Compile packages for regulatory submissions, including FDA, CE technical files.
- 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.
- Support regulatory and quality audits.
- Bachelor’s degree required (preferably in a scientific field)
- 1+ years’ experience of Quality Assurance and Regulatory Affairs of consumer medical devices
- Solid understanding and proven of ISO 13485, 21 CFR 820 QSR, ISO 14971, IEC 60601, IEC 62304 and software development lifecycle
- Thorough knowledge of cGMP requirements
- 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 email@example.com