מנהל /ת רגולציה למפעל מדיקל!

Ensure compliance with all relevant medical device regulations, including FDA, CE, ISO13485, and MDR.
Develop and implement regulatory strategies to support the introduction of new products and modifications to existing products.
Prepare and submit regulatory filings and ation to regulatory authorities.
Regulatory Knowledge and Expertise:
Stay current with changes in regulatory requirements and industry standards.
Provide regulatory guidance and support to cross-functional teams, including R&D, Quality Assurance, and Marketing.
Conduct regulatory risk assessments and provide solutions to mitigate potential compliance issues.
Documentation and Reporting:
Maintain regulatory files and documentation in compliance with regulatory standards.
Prepare regulatory reports and submissions, ensuring accuracy and completeness.
Coordinate with external regulatory consultants and agencies as needed.