Our office is located in Kfar Saba.
**Job Description**:
Product Development & Lifecycle Management
Ensure compliance with FDA and EU regulations and adherence to industry standards, with a strong focus on ISO 13485, IEC 60601 and ISO 14971.
Lead cross-functional teams through testing, V&V (validation and verification) phases, ensuring rigorous compliance with regulatory and quality requirements.
Lead and manage the Risk management activities, configuration control, ECOs and Quality Management Systems (QMS) and SOPs (Training, Post Marketing MRBs etc.)
Lead and conduct Product Design reviews from preliminary to concept stages PDR, CDR, FDR.
Interact with vendors including external labs or SMEs to lead the ISO tests required during product development stages.
Prepare technical data and reports such as qualifications test procedures, and acceptance test procedures.
Work closely with R&D, and marketing to define product requirements and features.
Please note: Only candidates who meet the must-have qualifications will be considered.
B.Sc in Engineering, Life Sciences or a related field- must-have
At least 4 years of experience in QA/RA within the medical device industry -must-have
Strong technical capabilities- must-have
Fluent in English- must-have
Hands-on and able to independently perform work
Excellent interpersonal skills
Team player with the ability to work independently
Creative problem-solving abilities
Capable of working under pressure
Prior experience working in a startup environment
