QA/RA Specialist

Clevaligner is an innovative software company in Herzliya developing an AI-based solution to assist orthodontists during patient treatments. The software provides a fully automated treatment planning process along with orthodontist control, allowing them to print aligners from their clinics.

Responsibilities:

We are looking for a QA/RA specialist with hands-on experience in the medical device industry, including regulatory compliance in the EU and the US. You will be involved in maintaining the company‘s quality management system and in regulatory compliance activities for the company‘s medical device software.

You will have the following key tasks and responsibilities:

• Manage the quality management system as a whole and support process owners in managing their processes
• Identify regulatory requirements in collaboration with Regulatory Affairs, perform gap analyses and coordinate the implementation
• Maintain the quality policy, quality objectives, and quality manual including process overview, key performance indicators
• Support the process owners to implement the policy, regulatory requirements, standards and guidance, and review procedures for conformance
• Organize and perform internal audits and manage external audits and inspections 
• Coordinate monitoring and data analysis activities
• Coordinate CAPA activities
• Review complaint and non-conformity reports 
• Ensure compliance and compose/review regulatory files (e.g. technical documentation, 510(k))
• Manage regulatory submissions, registrations and notifications
• Manage vigilance activities

Qualifications:

• Bachelor degree with at least 2 years' experience in QA/RA in the medical device industry
• Experience in QA/RA for medical device software and GDPR regulations
• Hands-on experience with CE marking and FDA clearance processes
• Good understanding of ISO 13485 and EU and US medical device regulations Cross-functional, risk-based and innovative thinking skills
• Experience in performing audits
• Good presentation and communication skills
• Good knowledge of English (written and spoken)
• Team-player

Nice to have

• Technical knowledge in software development (SaaS)
• Understanding of Cloud architecture and information system management
• Experience in leads-generation, digital marketing, participation to healthcare exhibitions 

We offer

• Joining a young, enthusiastic team 
• Competitive salary and extras
• A Part-time or full-time job (hybrid position)
• Chance to contribute to AI medical technology