Product-QA-RA lead

Annabella is a non-traded public company that markets a unique breast pump with a patented mechanism designed to imitate the baby's natural suckling.
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.