Regulatory Affairs And Quality Manager
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Job Description
Nanox AI has set out on a mission to help hundreds of millions of people receive access to fast accurate medical care through the design and development of medical devices of only the highest quality (Software as Medical Device SaMD).
We are looking for a Regulatory Affairs and Quality Manager to join our team and turn this mission into a reality.
The RA/QA Manager will manage the Regulatory Affairs and Quality team responsible for monitoring coordinating and maintaining the company s quality management system and processes and regulatory affairs in order to meet established quality standards and regulations and release top of the line products.
Responsibilities:
- Lead the regulatory team in preparing coordinating tracking and following up on approvals for medical device submissions including US 510(k) EU technical files Israel New Zealand Thailand and more as applicable.
- Implementing and maintaining Quality Management System (QMS) that complies with ISO 13485:2016 FDA 21 CFR Part 820 ISO 27001 GDPR HIPAA.
- Research plan prepare and obtain approvals for medical device submissions in growing global markets.
- Lead regulatory inspections and audits Responsible for the planning and implementation for company External audits by 3rd party (CE and FDA)
- Prepare review and approve product development documents including test product requirements risk analysis documents clinical validation protocols etc.
- Provides internal training on understanding interpretation and implementation of global standards and regulations.
- Works closely as key team member along with R&D Quality 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.
- Review and approve marketing communication materials.
- Act as liaison for communication with regulatory authorities or distributors regarding the company s regulatory filings; Potentially act as PRRC.
- Develop Annual Quality Planning administer 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.
- Responsible for Annual Internal Audits planning and implementation
- Planning of new employees Onboarding
- Conducting management reviews collection and data analysis
- Management of the Risk Management process
Requirements :
- A formal Degree in engineering or science discipline
- At least 10 years of experience in RA position in the medical device industry with knowledge of US European Israeli AMAR and international medical device regulation
- At least 10 years of experience in Quality Assurance positions in the medical device industry with knowledge in QMS implementation that complies with FDA 21 CFR Part 820 European Medical Device Regulation (MDR) ISO 13485 ISO 62304 and ISO 14971 standards.
- Managerial experience a strong advantage
- Experience in preparing documentation for regulatory submissions (510(k) CE technical files).
- Experience with software medical device (SaMD) regulation an advantage.
- Experience with AI an advantage.
- Certified ISO 13485 Auditor an advantage
- Ability to perform well in a fastpaced startup environment.
- Selfdriven communicative detail oriented and excellent interpersonal skills and attitude.
- Excellent written and verbal communication skills: Hebrew and English
- Able to produce positive results with a strong sense of urgency and ability to multitask.
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Full-time
