משרות והצעות עבודה

• Support investigation and resolution of quality events arising from production, incoming materials, and post-market feedback. • Participate in deviation management, non-conformance handling, and quality investigations, including root cause analysis and follow-up actions. • Take part in the development, implementation, and monitoring of corrective and preventive actions (CAPA) to ensure sustainable improvements. • Perform quality oversight activities on the manufacturing floor, including reviews, audits, and process monitoring. • Interface with suppliers on quality-related matters, including supplier qualification, performance monitoring, and corrective action follow-up (SCAR). • Support MRB activities, complaint handling processes, and quality documentation related to production and supplier issues. • Maintain and update quality system documentation in accordance with applicable standards and regulations. • Provide ongoing quality support to internal teams and promote quality awareness throughout the organization. Location: North District, Israel

1. Manufacturing Process Support • Monitor daily production activities, troubleshoot issues, and provide timely technical support to maintain output and product quality. • Optimize manufacturing processes through root-cause analysis, cycle-time reduction, and waste elimination. • Develop and maintain work instructions and Test Instructions. • Collaborate closely with production and engineering teams Resolve process challenges within production facilities 2. Process Validation & Compliance – • Execute and document qualification/validation activities (IQ/OQ/PQ) per ISO 13485 and FDA 21 CFR 820 requirements. • Lead engineering investigation and Failure Analysis activities in Operation, on component, product or process level 3. Equipment & Tooling management • Validate new equipment, fixtures, and tooling. • Support preventive maintenance programs and collaborate with maintenance to ensure equipment uptime. • Perform equipment capability studies and implement improvements. • Lead engineering activity regarding design changes (ECO), NPI, test method and tooling design, monitoring and continuous improvement of manufacturing processes • Design new Jigs based on improvement recommendations. 4. Supports MRB processes in Operation, assisting with issues relating to CAPAs, complaints and manufacturing support

The Sales Manager will be responsible for communication with customers, presenting new technologies to our customers, providing excellent customer service, driving sales, conducting training sessions, Application support, and managing sales activities. Responsibilities: Presenting high end solutions for the Israeli food, pharmaceutical and other local industries. Lead the Israeli market sales operations, end-to-end (Pre-sale, sale and post-sale cycle). Manage the commercial activities, negotiation and closing deals. Establish and execute the yearly sales plan based on the go to market plan in Israel. Prepare quarterly and annual sales forecasts. Manage the day-to-day customers relations management grow our country's customer base and manage the accounts. Maintain strong relationships with the various stakeholders in the field. Identify and address customer challenges and needs and represent the voice of the customer within the company. Build and grow customer loyalty and customer satisfaction. Continually analyze competitive landscape and environment within assigned accounts to determine trends and provide customer feedback to the company leadership.

The Head of CMC & Technical Operations will own end to end CMC and technical operations for preclinical and clinical stage RNA targeting oligonucleotide programs, including complex lipid / liposomal formulations. The role spans external development up to GMP manufacturing at CDMOs, from late stage process development and validation through clinical supply and preparation for commercialization, and leads all CMC contributions to global regulatory filings. Key responsibilities • Set the overall CMC and technical operations vision and roadmap for oligonucleotide drug substance and lipid / liposomal injectable drug product from Phase 1/2 through Phase 3 and commercialization, aligned with corporate strategy. • Lead selection, contracting input, and day to day technical, operational, and quality oversight of global CDMOs/CMOs for DS and DP, including oligo synthesis, purification, conjugation, liposomal formulation, sterile fill/finish, packaging, and testing. • Design and oversee process validation strategies (including PPQ) and implement robust control strategies and continued process verification for both DS and DP suitable for global registrations. • Direct analytical development, method qualification/validation, and stability programs for DS, DP, and critical raw materials (e.g., lipids, modifications) to support specifications, shelf life, and comparability. • Serve as CMC lead for all regulatory interactions: drive authoring, review, and maintenance of CMC sections of IMPD/IND/CTA and later stage dossiers (e.g., NDA/MAA), and coordinate timely, science based responses to health authority questions. • Ensure phase appropriate CMC documentation, including master batch records, specifications, validation protocols and reports, deviations, investigations, and change controls generated with CDMOs. • Partner closely with Clinical, Clinical Operations, and Clinical Supply to forecast needs and ensure uninterrupted GMP supply for global trials, including labeling, distribution, and returns strategy. • Build and maintain a resilient, cost effective global supply chain for oligonucleotide and liposomal products, including risk identification, mitigation plans, and contingency strategies for single source materials and sites. • Contribute to portfolio and program decision making with the CEO and executive team, providing CMC/Tech Ops input on timelines, risks, budgets, and scenario planning. • Recruit, lead, and develop a small, high caliber internal CMC/Technical Operations team appropriate for a highly outsourced model; establish clear objectives, governance, and ways of working with internal and external partners. • Support due diligence and technical assessments of new pipeline assets, delivery technologies, and manufacturing partners relevant to RNA targeting oligonucleotide therapeut Location: Center District, Israel

Manage and mentor a growing V&V team, fostering a culture of quality, accountability, and continuous improvement. Define and lead the V&V strategy, master plans, and schedules aligned to product development cycles and regulatory requirements. Coordinate V&V activities with external testing laboratories and vendors to ensure high-quality and timely deliverables. Champion continuous improvement of V&V tools, methodologies, and infrastructure. Oversee and execute verification and validation activities, including protocol design, testing, and documentation for capital systems and disposable devices. Ensure robust test method development, validation, and equipment qualification in accordance with industry and regulatory standards. Drive readiness for regulatory submissions and audits through comprehensive V&V documentation and compliance. Partner closely with R&D, Quality Assurance, Regulatory Affairs, Clinical, and Manufacturing teams to ensure integrated and risk-based V&V planning. Actively participate in design reviews, risk assessments (per ISO 14971), and contribute to the development and maintenance of DHF and DMR. Ensure all V&V activities comply with applicable regulatory standards, including FDA, ISO 13485, ISO 14971, IEC 60601, and EU MDR.

About the Role: As a Regulatory Affairs (RA) Manager – Europe, you will support the implementation and maintenance of regulatory systems and activities across the company’s medical device product lines. You will play a key role in ensuring compliance with global regulatory requirements throughout the product lifecycle, from development to commercialization and post-market. A major focus of the role will be the management of ongoing MDD-related activities and leading the company’s transition to MDR (currently in progress). The RA Manager will report to the VP of Clinical and US Regulatory Affairs. Key Responsibilities • Provide regulatory guidance and coordinate the preparation of global regulatory submissions, maintenance filings, notifications, labeling updates, and annual reports • Identify and address potential regulatory issues • Participate, as needed, in MRB, CAPA, ECO reviews, risk management sessions, design reviews, and management reviews • Support post-market surveillance activities, including complaint handling, vigilance reporting, promotional material review, and regulatory reporting • Assist in preparing and maintaining Technical Documentation, submissions to Competent Authorities (including clinical investigations), FDA submissions, and other global pre- and post-market regulatory filings • Support global distributors with local registrations • Ensure effective and timely training within the RA function on SOPs, processes, and regulatory guidelines • Collaborate closely with Clinical, Quality, and R&D teams to ensure alignment, compliance, and coordination of regulatory activities • Monitor project progress, maintain timelines, and proactively identify risks

ניהול והובלה של תהליכי גיוס מורכבים בעולם הביוטק: • הבנת המשרה לעומק ביחד עם הלקוח – גם בפן המקצועי וגם בהתאמה בין אישית לארגון. • פרסום המשרה בערוצים השונים וכתיבת פוסטים יצירתיים. • סורסינג תוך שימוש במגוון תוכנות וכלים (מערכת גיוס, לינקדאין, AI וכדומה). • ביצוע ראיונות טלפוניים ופרונטאליים. • ליווי תהליך הגיוס משלב פתיחת המשרה ועד לאיוש. • ניהול הקשר עם הלקוח ועם המועמדים לאורך כל תהליך הגיוס וגם לאחר מכן. *** העבודה מהבית, הגעה למשרד בחיפה יום בשבוע.

The Technical Project Manager – Responsible for full lifecycle management of R&D projects, including systems engineering, HW / SW and mechanical integration. Ensures projects meet technical, regulatory, and quality requirements, while coordinating execution, timelines, and resources across teams. The project manager interacts with all functions and levels throughout the company and outside the company, working in an international, multidisciplinary, and multi-project environment. The position reports to the Program Manager and requires ongoing communications with a team based in the US, Europe, and Israel. Responsibilities: • Lead the planning and implementation of R&D projects • Facilitate the definition of project scope, goals, and deliverables • Develop full-scale project plans, including timelines, tasks, and resource requirements • Monitor and report on project progress to all stakeholders. • Deep understanding of the technical details of the project • Provide technical leadership, lead problem-solving, and support the project team. • Ensure project deliverables meet the quality requirements Location: Sharon area (Hybrid)

The Clinical Operations Manager will be responsible for the planning, execution, and oversight of the compay's clinical studies and post marketing clinical activities, ensuring that studies are conducted in accordance with applicable regulatory requirements (FDA, ICH-GCP) and company standards. Key Responsibilities •Clinical Operations Leadership: Manage clinical operations, including study planning, site and investigator selection, managing negotiations with sites, study initiation and monitoring. In addition, clinical commercial activities, post-market clinical operations •CRO & Vendor Oversight: Select, contract, and supervise CROs, laboratories, and other clinical vendors to ensure quality and compliance. •Regulatory & Documentation Management: Lead the preparation, review, and maintenance of essential clinical documents — including study protocols, Investigator’s Brochures, informed consent forms, case report forms (CRFs), and clinical reports. •0Data Management: Oversee data collection, EDC systems, data review, and the generation of clinical summaries and metrics. •Site Management: Build and maintain strong relationships with investigators, site coordinators,). Ensure effective communication and timely issue resolution. •Monitoring Oversight: Review monitoring reports, track enrollment progress, and ensure timely follow-up on action items. •Compliance & Quality: Ensure all activities adhere to GCP, ICH, and FDA regulations as well as internal SOPs. •Reporting: Prepare progress reports, timelines, and risk assessments for internal management and regulatory stakeholders. •Collaboration: Partner with cross-functional teams (Regulatory Affairs, Clinical, QA, Operations, and R&D) to ensure alignment and readiness for submissions.

The role of Senior Physicist at the company involves designing the next generation of the product components, such as gradient coils and magnet systems, with a focus on creating affordable, lightweight, and reliable solutions. This requires a deep understanding of the underlying physics and a first-principles approach. As part of the early team in the company, you’ll have the opportunity to help define the company’s DNA, as well as your own career path.

About the Role: As a Regulatory Affairs (RA) Specialist, you will support the Vice President of Regulatory Affairs in developing, implementing, and maintaining regulatory systems and activities related to highly regulated (Class III) medical devices. You will play a key role in ensuring compliance with global regulatory requirements throughout the product lifecycle, from development to commercialization and post-market. Key Responsibilities: Provide guidance, draft, and coordinate the preparation of global regulatory submissions, maintenance filings, notifications, annual updates, product labeling, reporting, design reviews, and risk management inputs for assigned products in line with regulatory policies and requirements. Review information for accuracy, scientific soundness, and regulatory appropriateness before submission to regulatory agencies (FDA, Israel MOH, CE Technical Documentation, Health Canada, and other global authorities). Identify and address potential regulatory issues from product development through manufacturing and commercialization, including review of Engineering Change Orders (ECOs) for compliance. Participate in MRB, CAPA, complaint-handling meetings, ECO reviews, risk management sessions, design reviews, and management reviews as required. Support post-market surveillance activities, including complaint handling, promotional review, and regulatory reporting. Assist in preparing and maintaining European Technical Documentation, submissions for Competent Authorities in Europe (clinical investigations), FDA submissions (IDE, 510(k), PMA), Health Canada license applications, and other applicable global submissions for pre- and post-market products. Serve as RA representative on product development teams to ensure identification and incorporation of regulatory requirements during design, development, preclinical, and clinical stages of Class III medical devices. Actively contribute to design control, risk management, labeling compliance, and promotional material review processes. Monitor, interpret, and communicate evolving regulatory policies and requirements, ensuring timely adaptation to company processes and submissions. Ensure appropriate and timely training within the Regulatory Affairs department on company SOPs, processes, and regulatory guidelines. Collaborate closely with Clinical and Quality teams to ensure alignment, compliance, and synchronization of regulatory activities worldwide.

Act as design control SME: • lead the quality design control process: design inputs, verification, validation, design transfer, ensuring adherence to quality standards. • Guides comprehensive risk management activities throughout the product lifecycle, ensuring potential risks are accurately identified, assessed, and effectively mitigated to uphold product safety and quality. • Reviewing and approving V&V, protocols, and reports to meet quality compliance and procedures • Supporting activities related to Design Transfer: plan and execution • Lead the design review meetings: planning, data gathering, and review for compliance, meeting reviews reports. • Keeps a check on the drafting and updating medical device files/ documents. • Support audit activities: internal/suppliers/external audits, resolutions of gaps towards continuous improvements. • Builds effective relationships with internal and external stakeholders, providing guidance and mentorship to ensure alignment with quality standards and project milestones. Location: Haifa (On-site)

Your goal: Create a disruptive hardware/software radiology product for point-of-care clinical settings, including specifications, partner assessment, optimization, tradeoffs, prioritization, and execution, in collaboration with R&D, external partners, clinical team, and specialists (orthopedists, radiologists). You will do this by: Interacting with the potential market and stakeholders to understand and mobilize the psychology involved in bringing MRI capabilities to the point-of-care and embedding it in the current workflow. Coordinating regulatory, quality, and clinical requirements. Working closely with R&D teams in-house and with external partners as product owner, to deliver the product with optimal time-to-market, quality, and resources. Scoping and prioritizing activities based on business and customer impact. Serving as an in-house expert for our product and becoming the go-to person for all functional issues. Represent the voice of the customer within the company Long term: Collect and analyse feedback from customers, support, and other stakeholders to reshape requirements. Proactively engage customers, relevant internal stakeholders and key opinion leaders to provide input for product strategy and for planned functionalities, grow market share and improve customer experience. Drive new product launches.

General position. Here you can submit your CV that will enter our database. We will reach out to you as soon as a position opens. • שליחת קורות חיים למשרה זו מהווה אישור לשמירתם במאגר המידע של סטפ אפ קריירה, לצורך טיפול במשרה זו ו/או משרות נוספות. בכל שלב תוכל.י לבקש עיון או מחיקה

General position. Here you can submit your CV that will enter our database. We will reach out to you as soon as a position opens. * שליחת קורות חיים למשרה זו מהווה אישור לשמירתם במאגר המידע של סטפ אפ קריירה, לצורך טיפול במשרה זו ו/או משרות נוספות. בכל שלב תוכל.י לבקש עיון או מחיקה