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Clinical Expertise: Serve as a primary medical resource within the company, providing clinical insights and expertise to inform product development decisions.
Medical Oversight: Provide medical oversight throughout the product development lifecycle, from concept ideation to regulatory approval and post-market surveillance.
Clinical strategy: Involve in the clinical strategy discussions and decisions for our AI clinical product, aligning with the company's overall vision and objectives.
Clinical Validation: Design and oversee clinical validation studies to demonstrate efficacy and utility of our product, collaborating with external clinical partners as needed.
Cross-functional Collaboration: Collaborate closely with interdisciplinary teams, including data science, engineering, product management, and regulatory affairs, to integrate medical considerations into product development
Hands-On clinical tasks: Lead and execute hands-on clinical tasks including mapping, clinical requirements definition, training sessions, and more
Customer-Facing responsibilities: Support sales and customer success through active participation in clinical discussions, assist in the implementation plans and executions

As QMS Compliance Engineer you will be responsible for driving and supporting CT/AMI QMS compliance to international medical device regulations, ISO13485, and general quality system requirements. Additionally, you will be responsible for managing and monitoring CAPA activities.

Your role:

Ensure readiness for External Audits.

Support of the execution of external audits, internal audits and inspections including FDA, Notified Body and other 3rd party audits in CT/AMI.

Execution of internal quality audits.

Assists organizational units in addressing compliance deficiencies.

Global facilitation of the CAPA process per all relevant procedures.

Be the center of knowledge for all the CAPA practices and the Trackwise tool.

Support and present CAPA during internal and external audits successfully.

Provide other compliance support, including reviewing audit reports, including correct findings classification, and responses to audit findings for completeness and effectiveness and providing training on key compliance topics.

Support tracking and monitoring of audit finding action plans until closure, including assistance in the resolution to closure.

Support tracking and monitor key performance indicators (KPIs) and implement corrective actions as required.

Perform analyses and continuous monitoring in support of internal audits, management reviews, and external audits.

Supports the implementation of the Business long-range quality, regulatory and compliance policy. Supports managing plans for all QMS parts in scope while maintaining compliance and effectiveness throughout the duration of transitions.

As Clinical Development Scientist you will develop the clinical evidence strategy, execution and dissemination in support of assigned CT-AMI programs. You will provide input to the cross-functional team through strong critical scientific thinking to develop innovative solutions for evidence strategy development.

Your role:

Leading development of evidence generation strategies of assigned projects, working within a cross-functional team.

Creating subsequent clinical development / evaluation plans.

Developing strong collaboration with KOLs and Investigators.

Participate in the interpretation & dissemination of evidence generated from clinical evaluation plans such as Clinical Study Reports and Clinical Evaluation Reports.

Supporting clinical evidence discussions with regulators, advisory boards, associations and societies.

ART MEDICAL is a well-funded medical startup, developing cutting-edge technologies and products for the treatment of ICU patients. Our smART+™ platform is an intelligent, multi sensor-based enteral feeding system for the treatment in critical care patients, that aims to prevent life-threatening complications, and helps ICU patients recover faster and better. We are looking for an experienced, highly motivated and talented Project Manager to join us. If you are a self driven, team player, have a can-do and problem-solving attitude, and want to impact the future of patient care in the ICU, then you may be the person we are looking for! As a Project Manager at ART, you will be responsible for leading, managing, and executing multi-disciplinary projects plans and activities in compliance with Medical Device 13485 standards. The primary objective is to effectively achieve planned specifications, quality standards, timelines, and budgetary constraints and to continually improve the lifecycle management process. You will be responsible for highlighting needs to assure technical proficiency and quality deliverables. We offer a collaborative, multi-disciplinary workplace, a chance to learn with and from interesting and enthusiastic colleagues. A rapidly growing, working environment and growth opportunities.