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In this position, you will develop and execute regulatory strategy, work closely with R&D and Engineering departments to provide regulatory inputs relevant to product development and changes, write and submit submission packages to FDA, EU, and work closely with worldwide RA partners
Key Responsibilities
Actively contribute in the development of regulatory strategies for software and product development and approval, as well as product lifecycle maintenance. You will be able to support regulatory activities and global strategy for product launch.
Define and prepare document packages for US FDA regulatory submissions, EU MDR Technical Files, and international packages.
Assess product changes and their global regulatory impact.
Ensure timely license renewal and annual registrations for internal and external partners
Interact with internal marketing, R&D, QA, project managers as well as external Regulatory partners.
Recommend changes for labeling, design, manufacturing, marketing, and clinical protocols for regulatory compliance.
Perform and document regulatory assessments of life-cycle changes according to regulatory requirements of the U.S. FDA, E.U., and rest of world (ROW)
Identify and communicate regulatory risks and mitigations
Monitor and document post marketing activities, analysis of trends, vigilance processes.
Respond to Information requests from regulatory Authorities
Explore submission pathways and regulatory opportunities, and recommend the most appropriate route according to regulation and business needs and priorities
Utilize strategic regulatory thinking along with technical expertise to implement regulatory strategies for post-approval changes

we are looking for a Sr. NPI Technical leader.
The Sr NPI Engineer will be responsible to represent the Operation and lead new projects and transfer them to production including the following:
E2E OPS rep for all New Products Introduction cross functional, following PLCM.
Responsible for building Product/Production file, Product documentation, BOM, jigs/tools/Fixtures design
Manage TK vendors and Critical vendors
Responsible for moving from prototype to mass production, including PL establishment and manufacturing strategy
Responsible of full Design transfer process during the PLC stages.
Full cooperation under Program and Project managers guidance

Do you want to help us build the DNA of tech?
we are currently seeking applicants for Process Engineer.
In this position, the successful candidate will plan assigned operations or conduct functionally focused, in-depth analyses to ensure the continuous efficiency of services or to provide relevant data, information, and/or services.
What you will be doing:
Willingness to travel between sites located in Dimona and Beer Sheva
To operate within the production area, developing, implementing and managing manufacturing methods, processes and sequence of operations.
To define process requirements, working procedures, and provide equipment recommendations for product lines.
To execute Process-FMEA analyses, identifying possible sources of failures and taking measures to eliminate operational risks.
To define the process control methodologies and manage statistical process control systems to analyze out-of-control situations.
To liaise with Quality Assurance in responding to customer inquiries, and with Design Engineers to coordinate the launch of new products.
To monitor functional-specific trends and derive recommendations for their (incremental) improvements.
To execute focused research, create informative reports to support change or adaptation for processes and infrastructure systems.
To contribute to projects or processes to improve functional efficiency and effectiveness.
To take over the accomplishment of dedicated (local or function-specific) workstream, as part of an overarching infrastructure project.