QA and RA Lead

OncoHost is a precision oncology company. We have developed a liquid biopsy-based diagnostic test to predict treatment outcomes in cancer patients and identify potential causes for treatment resistance.

OncoHost is looking for a dedicated and experienced QA and RA Lead to join our team for a full-time position. In this key role, you will ensure that our products meet quality standards and comply with all relevant regulatory requirements. You will be responsible for developing, implementing, and managing quality assurance and regulatory affairs programs that support our mission to provide cutting-edge precision oncology solutions.

Key Responsibilities

Regulatory Affairs:

• Develop and maintain, with the assistance of external consultants, regulatory strategies to ensure successful product registrations and ongoing compliance throughout the product lifecycle.
• Prepare and submit, with the assistance of external consultants, comprehensive regulatory documentation for product approvals (IVDs, and CE markings) to appropriate regulatory bodies including the FDA, and the EU.
• Act as the primary point of contact with regulatory agencies and notified bodies, facilitating timely product approvals and resolving regulatory issues.
• Monitor and interpret evolving regulatory requirements and guidelines, effectively communicating changes and updates to relevant internal departments.

Quality Assurance:

• Develop, implement, and maintain, with the assistance of external consultants, quality management systems (QMS) that comply with relevant standards (e.g., ISO 13485, ISO 15189, 21 CFR 820).
• Conduct internal audits and manage external audits and inspections by regulatory authorities.
• Supervise quality investigations, ensuring thorough root cause analysis and the implementation of corrective and preventive actions (CAPA). Ensure all product testing, validation, and documentation adhere to regulatory and quality standards.
• Provide comprehensive training and support to staff on quality and regulatory requirements, fostering best practices throughout the organization.

Qualifications/Requirements

• Bachelor’s degree in Life Sciences, Biomedical Engineering, or a related field; an advanced degree is an advantage.
• Minimum of 5 years of experience in quality assurance and regulatory affairs in the medical device or in vitro diagnostic (IVD) industry.
• In-depth knowledge of regulatory requirements and guidelines (ISO 13485, IVDR, and FDA regulations).
• Proven experience in preparing and submitting regulatory documentation and managing regulatory submissions, specifically in the EU (IVDR) and the US. 
• Strong proficiency in quality management systems (QMS) and quality assurance processes.
• Excellent problem-solving skills and keen attention to detail.
• Strong communication and interpersonal skills, with the ability to collaborate effectively in a team environment.

Working Conditions

Hybrid model: Four days from the Binyamina office, with flexibility to work remotely one day per week.