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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.

Our R&D team is expanding!
We are seeking passionate and skillful student to join us in revolutionizing the plant based alternative protein market. Come and join us!
In this challenging position you will be part of a dynamic research team that develops state-of-the-art products for the food tech industry.
As a researcher you will:
Develop innovative ingredients for the food tech industry.
Identify and analyse new raw materials.
Develop laboratory and analytical methods.

Join our innovative start-up company, dedicated to advancing cutting-edge cell-based therapy solutions for common and severe clinical challenges.
We seek a highly motivated individual to lead the design and optimization of drug formulations, ensuring stability, efficacy, and safety for clinical and commercial use. The ideal candidate will have a deep understanding of regulatory requirements
Key Responsibilities:
Designing and optimizing formulations for cell-free therapy products.
Conduct formulation studies, stability assessments, and compatibility tests to evaluate product performance and shelf-life under physiological conditions.
Developing and maintaining comprehensive documentation, including formulation development reports, regulatory submissions, and manufacturing instructions, adhering to FDA regulations and guidelines.
Keeping abreast of the evolving regulatory landscape, emerging technologies, and scientific advancements in cell-free therapy to inform formulation strategies and ensure regulatory compliance.