לוח משרות דרושים ביוטכנולוגיה, לחיפוש זה נמצאו 172 משרות

Medison offers hope to patients suffering from rare and severe diseases by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets. As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead and work relentlessly to bring therapy to patients in need, no matter where they live. Our values are at the core of every action we take, and we are committed to going above and beyond for the benefit of the patients we serve. We are a dynamic, fast-paced company operating in over 30 countries on 5 continents. We are looking for out-of-the-box thinkers, people who are passionate, caring, agile, and adaptive, to join us on our mission. If you want to make a difference in people's lives, we invite you to join us! The Regulatory Affairs Appointed Pharmacist will supports all Regulatory Affairs activities, including but not limited to preparation of registration dossiers, ensuring compliance with regulatory requirements, drafting product documentation, developing patient leaflets, overseeing packaging design, and managing updates to product labeling.

Responsibilities:

* Provide professional regulatory advice to Medison’s business units and partners.
* Planning and executing regulatory activities, periodic updates of approved dossiers and managing the change control process for pharmaceutical products.
* Good relationships with regulatory authorities and Medison’s partners and advancing timelines in the registration processes.
* Preparing registration dossiers, including content verification according to SOPs, submission, and tracking of registration dossiers with the Ministry of Health.
* Preparing packaging materials, including review and submission in accordance with the Ministry of Health requirements and in compliance with the product's registration
* conditions.
* Handling all types of submissions, new products, changes, and renewals.
* Ensuring that publications intended for the medical staff comply with Ministry of Health requirements and adhere to the product's registration conditions.
* Preparing registration dossiers for medical devices, including submitting registration applications, renewing licenses according to SOPs, and supporting the company's
* medical equipment and devices unit with registration requirements.

City:
Petah Tikva

we are seeking a highly skilled and experienced Senior Chemistry Researcher to join our innovative team. This role involves leading advanced research projects, developing new formulations, and optimizing processes to enhance our product offerings. The ideal candidate will possess a deep understanding of chemistry and materials science, along with a proven track record of success in a research environment. . This role requires a strong background in conducting independent research, publishing findings, and leading projects aimed at developing new materials and enhancing existing processes

Duties and Responsibilities:
Lead and manage complex research projects focused on the development of new formulations and chemical processes.
Design and conduct experiments to test hypotheses and analyze results.
Collaborate with cross-functional teams to integrate research findings into new product development.
Prepare detailed technical reports, research papers, and presentations to communicate findings to stakeholders.
Mentor and guide junior researchers, providing technical expertise and support.
Stay current with industry trends, advancements, and regulatory requirements to ensure the company remains at the forefront of the field.
Contribute to the development of patents and intellectual property protection for novel discoveries.

We are seeking a Senior Carbon Program Lead to personally direct and execute the standard-related, technical, and data-driven architecture of our carbon program.

Position Overview
This is an individual contributor role for a subject-matter expert who will ensure data accuracy and methodological integrity across all stages of the carbon program. This includes ensuring correct application of the relevant methodology, oversight of soil sampling and lab analysis, robust monitoring and data handling, audit readiness, preparation of documentation for verification, and ensuring that project design remains aligned with methodology requirements as the project scales.

The ideal candidate is a self-driven expert who will maintain the programs full alignment with the latest methodology updates and independently identify and close data gaps through direct collaboration with teammates, partners, and laboratories.

Key Responsibilities
Validation, Verification& Reporting: Lead the hands-on preparation of Monitoring Reports and own the full verification process; personally coordinate reviews and findings with Validation and Verification Bodies (VVBs) and the relevant registry.
Methodology Authority: Serve as the lead internal carbon offset/inset methodology expert, while monitoring updates, revisions, and guidance issued by the relevant registry.
Quantification: Guide and review GHG calculations and data analysis, engage directly with the underlying calculations and results to ensure outputs are consistent with methodology, aligned with project design, and suitable for verification.
SOP Architecture: Contribute to the development and maintenance and oversee the implementation of Standard Operating Procedures (SOPs) for soil sampling, handling, and laboratory analysis.
Technical Alignment: Support the alignment of all laboratory and partner operations with our QA/QC requirements.
Partnership Management: Act as a main contributor to establish and maintain technical partnerships with laboratories, research institutions, and digital solution providers to strengthen methodological robustness.
Digital Innovation: support the integration of advanced tools to streamline and validate data inputs, personally driving the methodological integrity of these tools and processes.
Multi-Disciplinary Execution: Collaborate directly with agronomists, MRV teams, and technology partners to ensure accurate quantification of soil carbon and GHG emissions.
Strategic Advocacy: Proactively engage with the relevant registry and other peer working groups to directly influence updates and the methodologys evolution.

We are seeking a proactive and detail-oriented AI Regulatory Engineer to ensure that AI-based clinical features for ultrasound systems comply with evolving global regulatory requirements-particularly FDA regulations for AI-enabled medical devices.
This role is critical as AI has become a highly regulated domain, requiring specialized regulatory strategies, risk management approaches, and lifecycle governance. The AI Regulatory Engineer will work closely with AI engineering, clinical, quality, product management, and regulatory affairs teams to define and execute the correct AI regulatory and submission strategy across the full product lifecycle.
Job Description
Key Responsibilities:
AI Regulatory Strategy & Compliance:
Interpret and apply regulatory frameworks and guidance for AI-enabled medical devices, including FDA, EU MDR/IVDR, and global regulations.
Define and drive AI regulatory strategies for clinical ultrasound features, including SaMD and AI-enabled device functions.
Design and execute clinical validation strategy and plans for AI-driven ultrasound products in compliance with regulatory standards.
Support FDA submission pathways (e.g., 510(k), De Novo, PMA) for AI-based features, including AI-specific regulatory positioning.
Risk Management & Safety for AI:
Lead AI-focused risk management activities in accordance with ISO 14971, addressing AI-specific hazards such as bias, robustness, generalization risk, and clinical misuse.
Perform and maintain AI-specific risk analyses (e.g., AI FMEA, algorithm hazard analysis, clinical performance risk).
Ensure traceability between clinical requirements, AI behavior, risk controls, and verification/validation evidence.
Regulatory Documentation & Submissions:
Prepare and maintain AI-related regulatory documentation, including:
AI descriptions and intended use statements
Training and validation dataset descriptions
Performance evaluation and clinical evidence summaries
Algorithm change management and lifecycle documentation
Support creation of FDA-ready AI documentation, including transparency, explainability, and human-factors considerations.
AI Lifecycle & Change Management:
Define regulatory-compliant AI lifecycle strategies, including updates, retraining, and change impact assessment.
Support implementation of Predetermined Change Control Plans (PCCP) or equivalent AI lifecycle strategies.
Ensure alignment between AI development practices and regulatory expectations for locked vs. adaptive algorithms.
Cross-Functional Collaboration
Collaborate closely with:
AI engineers and data scientists
Clinical and medical affairs teams
Quality, systems, and V&V engineers
Product management and regulatory affairs
Embed regulatory and safety requirements early into AI design, data strategy, and clinical validation plans.
Regulatory Intelligence & Audits:
Monitor evolving AI regulations, FDA guidance, standards, and industry best practices.
Communicate regulatory changes and their impact on AI roadmaps and product strategy.
Support internal audits, design reviews, and external regulatory inspections related to AI and clinical safety.
Provide training and guidance on AI regulatory and safety topics to engineering and product teams.