דרושים » מדעי החיים, טבע וחקלאות » Non-Clinical Regulatory Lead

Our innovation team is expanding, and we are looking for a motivated and detail-oriented Lab Research Assistant to work under the supervision of the Senior Electrophysiology scientist who leads the research in the Electrophysiology Laboratory.

In this role, you will support research aimed at understanding the effects of TTFields therapy on cellular electrophysiological properties.
This is a hands-on role requiring technical expertise in cell biology and electrophysiology techniques.

This full-time position is located in our R&D center, Haifa, Israel, and will be reported to the Senior Electrophysiology and Analysis Scientist.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
Performing basic experimental tasks: supporting and performing electrophysiological recordings in accordance with the researchers' instructions
Operating scientific instruments and collecting data, managing an orderly record of experiment protocols and results
Supporting the day to day activities of the laboratory: preparing equipment, solutions and samples for experiments, and performing ongoing maintenance of laboratory equipment.

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 INSIGHTEC products.
Preparation and maintenance of regulatory submissions and registrations of INSIGHTEC 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 INSIGHTECs 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 INSIGHTEC 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 Insightec Quality Policy, relevant Quality Procedures & Standards, and privacy & safety rules.