QA/RA Specialist

Company Description

Spatz Medical is a global leader in battling obesity and weight loss. The world's first and only adjustable gastric balloon. With a presence in over 60 markets and a patient base exceeding 150,000, Spatz3 offers a unique customizable feature for improved weight loss results because one size does not fit all. The product is FDA approved and has demonstrated an impressive 84% success rate in clinical trials and real-world applications.

Role Description

This is a full-time position as a QA/RA Specialist role at Spatz Medical in Raanana, Israel. The QA/RA Specialist will be responsible for overall management of the QMS, in charge of regulatory files submission and maintenance, will oversee employee training and customer complaints.

Responsibilities

• Manage the medical device QMS
• Lead internal and external audits
• Maintain EU MDR technical files
• Prepare technical files for other registrations and submissions
• Handle CAPA
• Manage design control, including ECOs
• Handle and analyze customer complaints
• Control documentation, records, and changes
• Inspect and approve DHRs
• Oversee employee training

Requirements

• Life science, engineering, or other related bachelor’s degree- Must
• At least 5 years of experience in the medical device industry - Must
• Proven Experience with ISO 13485:2016 and EU regulations- Must
• Experience with medical device regulatory submissions such as FDA/EU MDR/other- Must
• Experience working cross-functionally in a fast-paced environment
• Excellent organizational and time management skills
• Fluent in English