לוח משרות דרושים רפואה ופארמה

The Regulatory Affairs Post-Market Specialist leads and executes key post-market activities to ensure compliance with the Israeli Ministry of Health (AMAR) and requirements. This includes managing adverse event (vigilance) reporting, coordinating Field Safety Corrective Actions (FSCAs), and serving as a regulatory contact for post-market issues in Israel. The role involves close collaboration with cross-functional and global teams to maintain the highest standards of quality and patient safety.

Responsibilities may include the following and other duties may be assigned:

Lead the execution and follow-up of Field Safety Corrective Actions (FSCAs) including coordination with internal teams, customers, and submission to the Ministry of Health (MOH)
Manage the adverse event (vigilance) reporting process to the Israeli MOH, ensuring timely and accurate submissions in accordance with local regulatory timelines and guidelines
Collaborate closely with internal stakeholders including global post market teams to ensure consistent and compliant execution of post-market activities
Serve as a regulatory contact for the Israeli MOH on all post-market issues, including adverse events, recalls, field actions, and periodic updates
Stay up to date with changes in AMAR regulations, MOH guidelines, and industry standards, and communicate potential impacts to management and relevant teams
Participate in the local recall committee or crisis response team in the event of product safety issues requiring urgent action
Provide training to local teams on vigilance reporting, complaint handling, and FSCA procedures to ensure consistent and compliant practices

R39882

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