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A Global medical high-tech Company located in Shoham, is seeking a Quality Assurance and Regulatory Affairs Specialist with experience managing the development of medical devices through the approval process. The ideal candidate will have a strong regulatory and quality knowledge throughout product lifecycle with aspects of effective management and strategy.
Responsibilities & Scope of work:
Supports and maintains EU- MDR submission related activities (QMS, Technical Files, GSPR and PMS) and liaises with regulatory authorities
* Participation in internal and external audits e.g., FDA, Notified Body etc. for regulatory affairs matters - Oversight and performance of routine QA activities such as: ECO, MRB, NC, Monitoring of Calibrations, Training and Qualification, Customer Complaints, CAPA, Document and Record Control, Approval of qualification and validation activities etc.
* Control of processes in compliance with the applicable regulations and company procedure requirements - Participate in Management Reviews and analyze quality data
* Work closely with R&D through product development process and design activities.
* Support risk management activities including hazard analysis and FMEA. - Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
* Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
* Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents including the Medical Device Regulation (MDR), and all other standards/regulations included within applicable scope.
* Support and improve company Quality Systems by creating a quality culture and provide ongoing education on compliance activities.
* Contribute towards accomplishment of departmental and corporate goals and objectives
* All other duties as requested by his/her manager.

Required Translational and Bioanalytical Research Associate
Job Description
The Translational and bioanalytical research associate will oversee the Companys translational and bioanalytical activities that are essential for drug development activities, preclinical and clinical. This typically includes bioanalytical methods development and use for pharmacokinetic and immunogenicity evaluation, as well as methods needed for pharmacodynamic exploration, such as cytokines, receptor occupancy, immunophenotyping, and a support for drug manufacturing development activities (CMC). The candidate will ensure the methods are developed, validated, and used with the highest degree of quality and compliance with international regulations.
The candidate will work with cross functional teams across the organization (preclinical biomarker/translational research, clinical development, clinical operations, CMC, regulatory, clinical data management) to ensure the successful PK and PD sample analysis for investigational drugs in our pipeline.
Be responsible for the bioanalytical methods required for our various therapeutic programs at preclinical and clinical development stage. This includes assay set-up, optimization, validation, execution, tracking of program and study timelines, review of bioanalytical protocols and reports
Propose format and strategy for pharmacokinetic and pharmacodynamic assays, immunogenicity assays such as ADA and NAb assay, flow cytometry immunophenotyping panels, Receptor occupancy assays, etc.)
Support the selection and the oversight of external advisors/Contract Research Organizations, including participating to quality assurance audits
Monitor internal and external work on bioanalytical methods
Collaborate with scientific colleagues in the R&D units from discovery to clinical teams
Maintain an up-to-date understanding of the state-of-the-Art literature, requirements, and regulatory guidelines for bioanalytical methods used in drug development
Present written and oral reports to preclinical units and management
Contribute to Project Management activities such as definition of activities, timelines, and costs/budgets
Contribute to the data analysis and summaries of results derived from pre-clinical and clinical sample analysis
Contribute to preclinical and clinical documentation definition and writing for the sections related to bioanalytical methods.

We are expanding our bioinformatics and engineering team under the Computational Discovery unit and seek an Integrative Immunologist to drive the generation of new computational projects, and conduct data analysis towards novel targets discovery and enhancement of our cloud-based computational biology platform.
The Integrative Immunologist will play a key role the in-silico identification of novel drug targets and novel biomarkers in immuno-oncology (IO), with the hope to extend the reach of cancer immunotherapies to new patient populations.
The Integrative Immunologist will report to the Head of Computational Discovery.
Drive the inception of new integrative computational discovery projects based on immunological hypothesis and technological edge
Provide on-going support for computational discovery projects via the review of analyses outputs and through usage of internal platforms
Lead literature review for selected topics and scope available datasets for specific projects
Work closely and routinely with computational scientists and software engineers
Present, visualize and communicate the analytics results and scientific insights to internal and external collaborators.