מומחה רגולציה

תיאור

• Develop regulatory strategy for submissions of new products and changes to existing products

• Support, prepare and coordinate regulatory submissions of new products or changes to existing products. 

• Prepare and maintain technical files and general safety and performance requirements

• Coordinate and communicate activities with external consultants and regulatory bodies

• Review DHF documentation to assure compliance with regulatory requirements.

• Review and interpret regulatory requirements during product development and communicate to the project team 

• Review of V&V protocols and reports to assure comprehensiveness, accuracy and clarity for regulatory submissions

• Support Risk Management activities

• Create, update and maintain standards list

• Support manufacturing activities 

• Provide requirements for, review and approve product labelling

• Support compliant handling