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In this role you will have responsibility for laboratory tests, preparation of working samples with advanced equipment under GMP and GDP procedures, producing results and in addition, any role related to the ongoing efficient functioning of the laboratory Our QC Analyst: Performs moderately complex tests and analyses to assure that products comply with established specifications Carries out calculations and prepares documentation that shows the results of tests performed Enters basic data into log books or computer databases. Performing and monitoring routine testing using laboratory instruments Recognizing problems during the analysis Supporting laboratory housekeeping, environmental and safety initiatives

We are looking for a Medical writer and Regulatory Affairs associate.
Primary function of the position:
Clinical scientific knowledge and writing skills to effectively and clearly communicate medical science information in writing. Generally, focus on either scientific medical writing, which includes clinical studies, and regulatory documents, scientific articles or marketing medical writing. Experience in regulatory aspects (RA), help to lead regulatory strategy and provide ongoing regulatory input.
Roles and Responsibilities:
Work with clinical teams and clients to understand the nature of the scientific work that they will be covering.
Assess data or products using medical expertise, and quickly develop expertise in new areas as needed for their writing.
Help to write studies for submissions to the FDA. The writing is also used in publications or medical journals, or for internal company use.
Comprehensive writing of clinical study reports, study protocols, annual reports, investigator brochures, risk/benefit analysis and integrated summaries from raw data.
Prepare abstracts, scientific exhibits, posters and verbal presentations.
Help with develop and write pharmaceutical training materials, eLearning content, video scripts, magazine articles, and presentations to be used by a variety of audiences.
Conduct comprehensive literature searches to enhance background understanding, and evaluate and analyze the information which will be written about.
Provide responses to regulatory agencies regarding product information or issues.
Maintain current knowledge of relevant regulations, including proposed and final rules. Help in manage activities such as audits, regulatory agency inspections etc.
Participate in the development or implementation of clinical trial protocols. Preparation and submission of regulatory agency applications, reports, or correspondence.
Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.

Power the Future with us! SolarEdge (NASDAQ: SEDG), is a global leader in high-performance smart energy technology, with over 5000 employees, offices in 34 countries, and millions of products installed in over 133 countries. Our diverse product offering comprises intelligent solar inverters, battery storage, backup systems, EV charging, and complete home energy management ecosystems. By leveraging world-class engineering capabilities and with a relentless focus on innovation, we strive to create a world where clean, green energy from the sun is the primary source of power for our homes, businesses, and just about everywhere we thrive As a Battery Certification Expert, you will be responsible for ensuring that batteries/Storage systems comply with regulatory standards and industry certifications. Your role involves overseeing the certification process for battery products, collaborating with regulatory bodies, and providing guidance to internal teams on compliance requirements. You will stay updated on evolving regulations and standards related to battery technology, ensuring that products meet all necessary criteria for safety and performance. You will participate and influence standards and regulations drafting in international standardization committees by forming alliances with the industry’s leading authorities and competitors. Additionally, you will work closely with engineers and product managers to address any compliance issues and facilitate the successful certification of battery products. .You will indirectly manage activities across multiple teams including R&D and Product management. What will you be doing:
* Manage the end-to-end certification process for battery products, including planning, documentation preparation, testing, submission, and communication with certification agencies.
* Stay informed about global regulations, standards, and certification requirements applicable to battery technology.
* Participating in International Standardization committees to influence current and future industry’s standards to provide advantage to SolarEdge’s products.
* Internal Guidance: Provide guidance and support to internal teams (engineering, product management, quality assurance) on compliance requirements, testing methodologies, and documentation needed for certification.
* Quickly learn and solve unfamiliar customer technical & commercial issues caused by local regulation laws.
* Identifies and recommends compliance with standards that apply to the company’s current and future products. Standards analysis includes periodic review of coverage by technical area, by relevance and by geographic market.
* Interacts with third party accredited compliance verification entities to ensure Engineering and Product Verification have accurate interpretation of standards clauses.

Country:
Israel

City:
Herzliya

For a company specializing in the development and production of machines and saws for cutting silicon and hard materials in the field of microelectronic components
Location: near Yokneam
looking for you
General Job Description : Working to develop & support new and existing products Department: Engineering & R&D Blades Reporting: Engineering & R&D Manager
Responsibilities:
• Optimize the materials, chemical process & procedure • Perform process experiments and optimization • Adapt of new technologies, designs of experiments and new laboratory techniques • Write experimental results and technical reports and present at group and R&D meeting • Record all process information regularly and clearly to allow review and generation of commercial process instructions • Perform application tests with application lab in order to qualify new blade performance • Creating and developing new products to meet market demand • Support and train new staff in all procedures, move R&D to production