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A pioneering med-tech company developing innovative inhalation technologies for precise drug delivery. Our mission is to enhance patient care by leveraging breakthrough technology to improve treatment outcomes.

We are looking for a cQP (Cannabis Qualified Person) & cRP (Cannabis Responsible Person) to join our Tiberias site. As cQP (Cannabis Qualified Person) youll ensures that each batch of product released for marketing is produced and tested in accordance with the quality and regulatory requirements.

As cRP (Cannabis Responsible Person) youll be responsible for drugs inventory movements in the facility and for fulfilling regulatory requirements. Moreover, ensures that each batch of product released for marketing is produced and tested in accordance with the quality and regulatory requirements.
Key Responsibilities
Responsibilities as cQP
Releasing cartridge production batches to the market after approval of quality assurance, ensuring compliance with regulatory and quality requirements, adhering to Eudralex volume 4, annex 16, guidelines.
Batch release approval documents will be personally kept by the CQP, available for authorities review, for a period of no less than 5 years.
Supervision of the production of cannabis products.
Change controls regarding manufacturing process review and, when applicable, plan approval.
Participation in solving quality issues and deviations in production.

Responsibilities as cRP
Contact with the relevant district pharmacist on issues related to the production or release of products.
Dangerous Drugs inventory log management.
Dangerous Drugs annual report to the IMCU: Preparation of annual reports for submission to the district pharmacist.
Control over the receipt of cannabis into the warehouse.
Supervising the preparation of shipments of finished products.
Preparation of rejected cannabis for destruction including full documentation.
Carrying out a monthly and annual cannabis inventory count.
Change controls regarding inventory management and procedural cannabis movements review and, when applicable, plan approval.
Control of procedures as needed.

Implementation and leadership of quality processes within the E3D projects
Leading risk surveys, review, and approval of product development documents/design changes
Working with departments in the organization, customers, subcontractors, and suppliers handling customer complaints, quality agreements, procurement specifications, complaints to suppliers, and more
Responsibility for defining the quality assurance requirements in the project and product

About the role:
we are a fast-growing, global leader in energy-based solutions for Aesthetics and Eye-Care. We are based in Yokneam, Israel (with offices in Tel-Aviv) with a strong business performance worldwide.
We are looking for a Clinical Manager for the Aesthetics Business Unit, which includes a broad portfolio of leading solutions in the market as well as an exciting innovation pipeline. The Clinical Manager will be responsible for pre and post-market activities for the assigned platform including: clinical requirements guiding design input, pre-clinical testing, clinical input to regulatory submissions, 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 clinical value and benefits of the solutions.
Key responsibilities:
Develop and manage clinical project plan, timelines, and budgets end to end; clinical research, through pre-clinical evaluations, clinical trials and publications, to user guidelines and post-market evidence generation.
Form and cultivate strong collaborative relationships with cross-functional partners in R&D, product, marketing, and regional teams
Coordinate internal cross-functional teams, as well as external clinical research associates, data managers, and biostatisticians
Oversee the execution of clinical studies, ensuring adherence to protocols and regulatory requirements
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
Communicate project status to stakeholders and provide updates on milestones and deliverables
Identify potential risks and implement mitigation strategies to ensure project success.

About the role:
we are a fast-growing, global leader in energy-based solutions for Aesthetics and Eye-Care. We are based in Yokneam, Israel (with offices also in Tel-Aviv) with a strong business performance worldwide.
we are looking for a Product Marketing Manager for the Aesthetics Business, which includes a broad portfolio of leading solutions in the market as well as an exciting innovation pipeline. The Product Manager will be responsible for driving the business growth of the assigned product portfolio and oversee the 360 product aspects of the products.
Key responsibilities:
Coordinating the assigned products activities in a multi-functional organization; including marketing, sales, operations, engineering, and services teams, while ensuring compliance with quality systems and regulatory requirements
Owns and leads all product aspects relating to the assigned products, from product inception to launch and throughout the commercial lifecycle of the product.
Develop the product requirements based on customer and patient insights, needs and business aspects and follow them throughout the product development process.
Owns the product value proposition and associated claims. Develops the product marketing toolkit including educational, sales and marketing tools.
Perform business intelligence, market & competitive analysis and translate them into actionable business goals.
Develops global go-to-market strategies in collaboration with regional teams (segmentation, targeting, positioning, pricing) to drive market share and profitable growth.
In cooperation with the Clinical department, developing educational tools and programs for customers on clinical value and product use to drive adoption of our offering in the field.
Take an active part in the strategy and roadmap discussions of new product introductions
Be the Product Champion! Instill a sense of excitement about our products within the organization, and the relevant community as a whole.

we are a global leader in energy-based solutions for Aesthetics and Eye Care. With more than 1000 employees worldwide and sales in over 100 countries, we are headquartered in Yokneam and have offices in Tel-Aviv.
What makes this opportunity so BIG:
You will work with various functions to develop new products and
manage commercially available products via collaboration with Regional
counterparts, R&D, Regulatory, Clinical, and Business Development.
Heres what youll be doing:
Product Strategy, New Product Development & Product Life-cycle Management
Support product development decisions for current and future products.
Generate business plans, market requirements documents, presentations and supporting materials to align all functional groups behind a common product vision.
Lead product roadmap and planning within the category
Drive claims development for products
Understand patient experience with product portfolio
Provide portfolio scenario planning and value assessment
Conduct market research to uncover customer and business insights; translate those insights into products and programs that deliver growth for the product category
Understanding and analyzing competitive landscape
Represent the category during medical conferences, sales meetings, and customer visits
Maintain strong clinical and product knowledge; support internal and external customer education programs and product training as required Basic Qualifications
Travel approximately 1-2 trips per quarter.
Cross-Functional Team Participation & Leadership
Work closely with R&D teams to build roadmap and bring new products to market
Collaborate with clinical team on developing clinical studies, drive product and protocols enhancements and new product development
Participate in cross-functional teams to optimize future product strategy around given business needs, market needs, customer needs and technical capabilities.
Work with marketing partners to understand unique customer & business needs and ensure product requirements are aligned with global products and strategies.
Interact with Business Development team to identify acquisition, licensing and other partnership opportunities.

Manages and train Regulatory Affairs representatives and associated processes for preparation of product submissions, including 510(K), CE Technical Files (MDD and MDR), China, Canada, Japan, South Korea, and Australia and other International Countries.
Interact with Internal and External teams on regulatory related projects to meet regulatory compliance topics and regulatory tasks.
Lead the development and implementation of regulatory strategy for assigned projects of the relevant BU
Collaborate with Sr. Director Regulatory regarding EU, China, Japan, South Korea, Taiwan and other global territories regulatory teams for to implementation of develop global regulatory strategies for projects and submissions.
Approving labeling (including advertising and promotional materials) in the context of submissions or registrations and serving as the regulatory expert of the projects.
Provide regulatory advice and guidance to Regulatory Affairs representatives, engineering, and project teams to ensure submissions meet regulatory requirements and maintain up-to-date knowledge of regulatory requirements.
Manage, mentoring and train International Regulatory Associates/Leads for product submissions.
Will support and partner with Internal teams and functions in phases of design, development, production, and distribution of medical devices.
Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.

The Complaints Investigator will be responsible to Conduct costumer complaint investigations, identify root causes and issue an investigation report. Additionally support reportability assessment to the FDA.

Main responsibilities:

Conduct and lead customer complaint investigation related to mechanical issues, hardware issues, software issues, handling issues or production issues.
Work closely with the representative team in order to understand the nature of the complaint.
Work closely with SW and HW engineers, as well as the product team to determine the root cause of failure and ensure investigations are in compliance with the companys applicable policies.
Communicate and escalate investigation results and facilitate failure investigation decision process.
Provide recommendations to prevent failure recurrence and support for nonconformance/CAPA and ECO actions.