Regulatory and Quality Affairs (RA/QA) Specialist

As a Regulatory Affairs and Quality (QA/RA) Specialist in Nanox AI (Software as Medical Device- SaMD Company), you will be responsible for maintaining the company’s Quality Management System (QMS) and processes, in order to meet established quality standards and regulations. You will also take part in product registration and regulatory approvals of Nanox AI’s products all around the world.

Requirements:

A formal degree in engineering or science discipline
2-3 years of experience in Quality function in Medical Device company with QMS implementation that complies with FDA 21 CFR Part 820, European Medical Device Regulation (MDR), ISO 13485, ISO 62304 and ISO 14971 standards.
2-3 years of experience in RA position in the medical device industry, with knowledge of US, European, Israeli AMAR, and international medical device regulation – a significant advantage
Experience with Software as Medical Device (SaMD)- an advantage.
Excellent written and verbal communication skills: Hebrew and English.
Experience in preparing documentation for regulatory submissions (510(k), CE technical files) - an advantage
Experience with software medical device regulation - an advantage.
Certified Auditor- an advantage
Ability to perform well in a fast-paced startup environment.
Able to produce positive results with a strong sense of urgency and ability to multitask.
Detail oriented, demonstrated success in a start-up, entrepreneurial work environment
Good communication skills
Self-motivated, able to manage priorities

Responsibilities:

Implementing and maintaining Quality Management System (QMS), that complies with ISO 13485:2016, FDA 21 CFR Part 820, ISO 27001, GDPR, HIPAA.
Collaborate in research, planning, preparing, and obtaining approvals for medical device submissions in growing global markets, including US 510(k), EU technical files, Israel, New-Zealand, Thailand and more.
Develop, deploy and maintain quality assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements. Continuous improvement of Quality assurance processes and procedures.
Prepare, review and approve product development documents, including test product requirements, risk analysis documents, clinical validation protocols etc.
Coordinate and provide company internal training on understanding, interpretation and implementation of global standards and regulations.
Work closely as key team member along with R&D, Clinical, Product management and Business on all aspects of product life cycle.
Review, approve and execute all forms of quality systems requirements such as CAPAs, change orders, regulatory assessments etc.
Represent Regulatory Affairs on change controls and provide regulatory assessment.
Review and approve marketing communication materials.
Act as liaison for communication with regulatory authorities or customers regarding the company’s regulatory filings.
Non-conformities and Customer Complaints recording and tracking.
Collection and data analysis for reports (i.e. Management Reviews)
Participate and support during company External audits by 3rd party (e.g. CE and FDA)