לוח משרות דרושים מכשור רפואי

Lead and manage clinical regulatory submissions, including IDE submissions, IRB/EC applications, amendments, and ongoing study maintenance.
Serve as the regulatory lead for US and EU clinical investigation activities, supporting first?in?human, feasibility, and pivotal studies.
Prepare, review, and maintain clinical regulatory documentation, including protocols, Investigators Brochures, clinical risk sections, and regulatory responses.
Support regulatory strategy development for clinical programs, ensuring alignment with development, clinical, and business objectives.
Act as a primary regulatory interface with FDA and European regulatory bodies related to clinical studies.
Collaborate closely with Clinical, R D, Quality, Biostatistics, Operations, and external clinical partners/CROs.
Participate in cross?functional discussions supporting new product development and clinical evidence

We are seeking a Lead Systems Engineer to drive Point-of-Care Ultrasound systems engineering activities across the full product lifecycle.
Job Description
Key Responsibilities:
Lead and manage system-level requirements and specifications throughout product development
Drive system verification and validation activities, including end-to-end system testing
Act as the primary interface between Algorithm, Software, and Verification & Validation (V&V) teams
Lead product risk management activities in accordance with regulatory and quality standards
Drive resolution of complex technical issues to ensure project milestones and goals are met
Collaborate closely with Program Management to support scheduling, mitigate technical risks, and inform decision-making through sound engineering judgment.

Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.

Essential Functions

Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.

Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.

Assist with periodic review of study files for completeness.

Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.

Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.

May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

May collaborate with the clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.

Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.

The role will be Hybrid and require visits to the sponsor office weekly.

Sponsor requirements are:
Strong local experience and knowledge in Israeli regulations and submissions.
Beside the role being a lead role, it requires a lot of local regulatory knowledge.
Fluency in Arabic.


Essential Functions

Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.
Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.

In this onsite role, the Team Leader Quality Operations leads a team of Quality Engineers that support manufacturing processes and projects, as well as provide quality oversight to the Engineering department within a multi-functional team environment for medical devices. This Team Leader will lead QEs, projects and tasks, from product inception through commercial product and play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all applicable regulatory requirements. Additionally, this role will identify and implement improvements within the Quality Management System. The Senior Quality Engineer will be a strong advocate for product, process, and system quality at all stages of manufacturing processes.

Essential Duties and Responsibilities
Exhibit a strong quality first mentality and ensure that products, processes and quality are held to the highest standard, adhere to all company policies, KPIs and follow all safety rules and safety procedures
Lead QEs daily activities, provide support, guidance, set objectives, monitor performance, and follow-ups as required.
Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards.
Responsible to provide support to manufacturing related processes, such as (but not limited to) approval of equipment qualification, process risk management and pFMEA, and process validation documents (URS, IQ, OQ, PQ, etc.), and responsible to review, and approve product development DHF documentation (product specifications, design verification & validation activities, FMEA risk documents, test methods, protocols, reports, OOSs, product transfer to operations, etc.) in relation to medical devices.
Lead the Quality involvement in development and maintenance of product and hazard analysis in accordance with West policies and procedures.
Provide Quality oversight of qualification/validation/review and approval of documentation and reports/design controls activities to other QEs
Work cross-functionally with individuals and project or extended teams to provide guidance and ensure success of projects.
Responsible to review and approve process development QMS procedures and work instructions and support QMS activities as required.
Liaison with company and customers on Quality matters related to engineering projects.
Support routine sterilization validation monitoring activities.