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Required Clinical Affairs Manager.
* Design, plan, oversee, and manage research and clinical trials activities.
* Ensure that clinical trials are conducted in compliance with regulatory requirements, ethical standards, and company policies.
* Support regulatory submissions and annual reporting.

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

Our company is a fast-growing, global leader in energy-based solutions for Aesthetics and Eye-Care.
We are based in Yokneam (with offices also in Tel-Aviv) with a strong business performance worldwide.
Our company is looking for a Clinical Director for the Aesthetics Business, which includes a broad portfolio of leading solutions in the market as well as an exciting innovation pipeline.
The Clinical Director will be responsible for pre- and post-market activities for the assigned product portfolio and will lead a team of Clinical Managers.
The Director will own all clinical aspects including: pre-clinical, clinical input to regulatory submissions and registrations, market conditioning for new solutions, post-market evidence generation and KOL development.
The individual will serve as a major pillar in building relationships with global KOLs and demonstrating the value of benefits of the solutions.
Key responsibilities:
- Own the Clinical Strategy for assigned portfolio and be a key contributor to overall Business strategy.
- Lead all R&D clinical activities for assigned portfolio including: bench-top, pre-clinical ex-vivo and in-vivo, validation, usability and more.
- Lead post-market clinical activities for evidence generation and training: clinical trials and different clinical activities (sponsored, IIT, grants) according to GCP(ISO-14155/MDR/CFR) and following company SOPs, protocol development, training development and more.
- Lead the clinical input and support for key regulatory submissions and processes: regulatory submission clinical input, clinical validations, CER, CDP, CEP and more.
- Support marketing/commercial activities from the scientific/medical point of view: review and input to marketing collateral, develop white papers, active participation in scientific meetings and more.
- Lead a team of clinical managers and oversee the relevant budget.
- Form and cultivate strong collaborative relationships with cross-functional partners in R&D, product, marketing and regional teams.

We are looking for a Clinical Affairs Manager to implement and oversee all activities related to clinical research and clinical studies in the company.
DiA Imaging Analysis provides AI-powered solutions to make ultrasound image analysis smarter and more accessible.
Its AI-based solutions help ultrasound users acquire the right image and analyze it automatically, allowing them to identify clinical abnormalities that are often difficult to find visually and enabling them to make better decisions based on accurate and objective data.
Your role:
Designing and managing the execution of clinical studies that demonstrate medical product safety and efficacy.
Ensuring that trials are conducted in full compliance to GCP.
Full responsibility on sites initiation, site personnel training and monitoring.
Working closely with the principal investigators and study coordinators.
Working with regulatory, development and marketing teams to create scientific publications, clinical marketing material and clinical background required for regulatory submissions.