Your mission
Your Mission: You will be responsible for the development and upkeep of regulatory documentation to ensure compliance with global standards. Key tasks include:
- Develop and execute regulatory strategies aligned with business objectives
- Create, submit, and maintain regulatory documentation, including technical files and submissions required for compliance
- Liaise with Research & Development to create and maintain technical files
- Liaise with notified bodies, health authorities, and other relevant stake holders on behalf of the organization
- Monitor regulatory changes and ensure products adhere to evolving requirements
- Ensure alignment of departmental objectives and integration of regulatory requirements into product development through direct interdepartmental communication
- Conducting literature reviews and clinical evaluations