Regulatory Affairs Specialist לחברת מדיקל

Responsible for product submissions, global registrations and communication with authorities
Prepare and maintain technical documentation and regulatory files in compliance with applicable standards
Ensure compliance with global regulations, standards and guidelines
Assist in the development of regulatory strategy and updates strategy based upon regulatory changes
Assess the impact of any product changes, process modifications, or updates to existing regulations and manage notifications of change
Support Product development projects from Regulatory perspective
Provide training and support to internal teams on regulatory requirements and best practices
Support audits (both external internal) presenting Regulatory materials and with Regulatory inquiries
Review and update as necessary promotional material, labelling and SOPs for compliance with local and global regulatio