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We are looking for a Regulatory Affairs Specialist.
What you will be doing:
Provide regulatory support to the Development and Post marketing activities related to products.
Preparation and maintenance of regulatory submissions and registrations of products in relevant markets.
Review complex reports, validations, etc. for scientific merit and regulatory appropriateness; Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
Preparation and maintenance of annual renewals of Establishment Registrations, Device Listing, and other pertinent regulatory licenses.
Review of customer complaints to determine reportability according to regulatory requirements and execution of reporting per determination.
Provide ongoing regulatory support and assessments to different QMS related processes (e.g. MRB, CAPA, Contract review)
Actively participate in the evaluation of changes to the QMS documents and device design/process for impact on pending or existing registrations
Provide support for all external/internal audits at HQ and globally, as needed
Advise project teams on premarket regulatory requirements, labeling requirements and/or other compliance issues.
Work closely with various other teams (e.g. R&D, Operations, Quality, Marketing) both locally and around the world, to provide regulatory inputs as needed.
Monitor and advise the organization of upcoming or new guidance, regulations, agency/industry initiatives, etc. to ensure ongoing regulatory compliance
Attend other regulatory related needs, as required
Working according to Quality Policy, relevant Quality Procedures & Standards, and privacy & safety rules.

We are looking for a System Verification Engineer.
About The Position:
Define System Verification based on System (SW/HW) Design Inputs:
Study design/reliability requirements.
Take part in design reviews.
Define and execute feasibility experiments for proof of concept/design.
Establish Verification Equipment, Verification Methods and Infrastructure:
Define, develop, and maintain testing equipment and methods to provide the means to execute verification.
Collect and analyze data for improvement of methods/processes.
Plan and execute Design Verification and Process Validation for:
Developed products and processes.
Engineering Change Orders.
Service/Manufacturing equipment and processes.
Prepare and release Verification Reports:
Based on collected, analyzed data vs. pre-defined acceptance criteria.
In compliance with companys QMS and applicable standards/regulations.
Participate in the following forums:
Design reviews
Product development gates and milestones.
Initiate, manage, and monitor external testing contractors, such as Testing Houses and Labs.
Define and prepare testing to be performed by external contractors.
Identify and study relevant standards and guidelines (e.g. transportation/shelf-life standards).
Track, review and approve external testing reports.
Working according to Quality Policy, relevant Quality Procedures & Standards, and privacy & safety rules.

We are looking for a Tactical Buyer.
What you will be doing:
Request and analyze quotations, negotiate pricing and terms, and issue purchase orders.
Update ERP with purchasing status and due dates
Follow up and control of parts availability to execute sales needs
Monitor inventory levels and coordinate with logistics to ensure timely delivery.
Develop and maintain strong relationships with suppliers and internal stakeholders.
Improve purchasing efficiency
Coordinate shipments to and from vendors
Expedite purchased items according to priorities
Handle returns/MRB items with vendors
Support handling of vendors invoices
Support operations logistic tasks
Coordinate vendor opening and approval
Follow up purchase order signing process
Maintain Vendors Price Lists

We are looking for a VP Global QA.
The job holders duties and responsibilities include any of the following:
Act as Quality Management Representative
Responsible for the quality management system
Lead the Quality Assurance team
Lead the company to meet its annual quality goals
Lead quality data analysis
Update company management on quality performance and policy implementation
Define and maintain quality aspects processes for relevant quality related activities
Lead and ensure company compliance with quality standards and certifications as required
Lead and prepare the company for internal and external auditing authorities as required
Support company teams with QA requirements and processes
Act as the person responsible for regulatory compliance (PRRC)

looking for a Nodejs Developer to join our R&D team.
you will lead with us the way to be the best development company. Be it cutting edge technology adoption and implementation, nurturing our elite development team, or embracing new processes and models. And you will ​assist our customers to spearhead their fields