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Vigilance Specialist
We are looking for a Vigilance Specialist to join our team! Location: Netanya BioProtect Ltd is a leading medical start up in radiation protection technology. We offer spacers protecting healthy tissue during radiation oncology treatments, based on proprietary biodegradable balloon technology. The balloons suit a wide range of clinical applications in the fields of oncology and general surgery. The company’s first product, the BioProtect Balloon Implant, protects healthy tissue in patients undergoing radiation therapy for prostate cancer. The opportunity: As a Vigilance Specialist at BioProtect, you will be responsible for complaint handling and for ensuring the quality of complaints is within specifications and in compliance with Medical Device Reporting (MDR), regulatory requirements, and the company’s procedures. You will also drive cross-departmental collaboration to improve product safety and oversee Post-Market Surveillance (PMS). In this position you will be asked to: • Executing vigilance activities for medical devices, with a focus on identifying, evaluating, reporting, and analyzing trends in adverse events and complaints. • Process events to determine complaint status. • Perform adequate, accurate, detailed and timely complaint investigations. • Perform tasks to obtain adequate information to ensure proper documentation and closure of each complaint. • Collaborate with relevant teams including technical, Clinical, Field/Sales including returned product analysis • Complete applicable Medical Device Reports (MDR) as required per internal policy & procedures and CE/FDA regulations. • Support internal systems, methods, and procedures to maintain compliance.
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QC Inspector
We are looking for Quality Control / Quality Assurance professionals to join our team! Location: Netanya BioProtect is a well-established Israeli medical device startup, at the forefront of medical innovation in radiation protection. We develop and manufacture products designed for a wide range of clinical applications in oncology and general surgery. The company’s first product, the BioProtect Balloon Implant, protects healthy tissue in patients undergoing radiation therapy for prostate cancer. What We Offer: In this role, you will be part of BioProtect’s Quality Assurance (QA) team, participating in quality control inspections and product release processes for life-saving products that improve patients’ quality of life. We offer excellent conditions for suitable candidates – competitive salary, advanced study fund from day one, meal card, and more! Responsibilities: Performing incoming quality control (QC) inspections for raw materials and equipment, and releasing materials in the Priority system. Conducting in-process inspections and product release testing. Reviewing batch records and product release documents, ensuring compliance with strict standards (FDA, CE, AMAR). Entering data into the Priority system. Conducting manufacturing inspections in both Hebrew and English, ensuring compliance with stringent standards (FDA, CE, AMAR). Working with measurement tools and computer systems.
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