לוח משרות דרושים מנהל רגולציה משרה מלאה

1. Be part of the company management team with responsibility to lead regulatory strategy planning for company products. 2. Responsible to prepare regulatory submissions across all products and platforms as needed. 3. Review and present to the management and CEO regulatory updates and status reports. 4. Responsible for the development and preparations of regulatory submissions across all products and platforms as needed. 5. Be the point of contact for all regulatory inputs and deliverables from headquarters for product and clinical research submissions. 6. Responsible for maintenance of product regulatory files and registrations (NoC, registration renewals, annual reports etc.). 7. Provide regulatory support to R&D - project regulatory requirements, assure adherence to the regulatory path and resolve emerging conflicts with regulatory requirements. 8. Responsible to provide regulatory support to manufacturing, logistics, engineering, supply chain and sales teams. 9. Responsible for regulatory assessment of customer complaints, reportability assessments and MDR’s to regulatory agencies. 10 . Act * as the person responsible for regulatory compliance (PRRC), responsible to ensure the following:
* The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
* All post market surveillance and reporting obligations are met, including reporting of serious incidents and field safety corrective actions, trend reporting, analysis of serious incidents and field safety corrective actions and analysis of vigilance data.
* For investigational devices projects , the statement referred to in Section 4.1 of Chapter II of Annex XV of the EU medical device regulation (MDR) is issued. * This is a joint responsibility with VP of Global QA, where VP RA is the main responsible for the above activities

The Regulatory Affairs Specialist will be part of the Regulatory team at the Caesarea site, reporting to Regulatory Affairs Manager, supporting ongoing activities as required. The individual will serve as Regulatory Affairs representative in various workstreams.
Responsibilities may include the following and other duties may be assigned:

Regulatory assessments and registrations worldwide
Write, update and maintain technical files for Class I, IIa and IIb
Support global regulatory requirements and submissions
Support QMS changes, PMS and CAPA activities related to the regulatory field
Responsible for labeling requirements and compliance
Note: The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.

R44331

This hybrid position is based in Yokneam, Israel/Santa Clara, California/ Lafayette, Colorado facilities. The role requires occasional travel and involves independent work to maintain quality standards across global operations.
Responsibilities may include the following and other duties may be assigned:

Provide oversight for development and maintenance of quality management systems, ensuring full compliance with FDA, ISO 13485, and other regulatory requirements
Lead audit and inspection preparation activities, coordinate with regulatory bodies, and manage resolution of findings through comprehensive Corrective and Preventive Actions (CAPA)
Conduct process analysis and risk assessments to identify improvement opportunities and ensure adherence to quality standards across manufacturing and design operations
Collaborate with cross-functional teams to interpret regulatory requirements and implement quality policies that support our endoscopy and surgical device portfolios
Prepare detailed quality reports and documentation for internal stakeholders and external regulatory agencies
Facilitate global quality standards implementation and best practice sharing across international sites

R41483