Lead project Manager for implementation of new processes and procedures. Ensured compliance with regulatory requirements. Developed and implemented QA/QC analysis.
Supported manufacturing operations and audits of the customer complaints. Provided technical support to the product development team. Reviewed and revised the final release of products.
Created and implemented a comprehensive management system for the project. The project was adopted by the US and Europe.
Developed and implemented a system to track and analyze data to ensure compliance with applicable regulations. Performed quality assurance reviews and provided feedback to the management.
Regulatory Affairs Coordinator
Served as a liaison between the clinical trial sites and the FDA and the regulatory authorities. Assisted in the preparation of regulatory documents for the distribution of communication.
Responsible for the submission of regulatory documents to the medical Affairs department, including the following: The review of the informed consent process, and the development of the regulatory documentation for the content of the IND.
Ensured compliance with all regulatory requirements and federal regulations for the company. Reviewed and submitted regulatory documents to the FDA.
Coordinated with the investigational sites to ensure proper storage and shipment of clinical supplies. Performed monitoring of all SAEs and reported deviations to the IRB.
Ensured that all regulatory documents were up to date and followed. Provided technical advice to the client. I was also trained in the use of the new products.