Are you familiar with Quality Management Systems (QMS) and ISO standards? Please provide examples.

Yes, I am familiar with Quality Management Systems (QMS) and ISO standards. In my previous role as a Regulatory Specialist, I worked extensively with QMS and ISO standards to ensure compliance with regulatory requirements. For example, I conducted regular audits of our QMS to identify any gaps or areas for improvement. I also participated in the development and implementation of ISO 9001 quality management processes, which involved creating and updating standard operating procedures, conducting training sessions for employees, and performing internal audits to ensure compliance. Additionally, I have experience in preparing and submitting regulatory documents in accordance with ISO 13485 for medical devices.

Yes, I am very familiar with Quality Management Systems (QMS) and ISO standards. In my previous role as a Regulatory Specialist at XYZ Company, QMS and ISO standards were integral to our daily operations. I was responsible for managing our QMS, which included developing and implementing quality processes, conducting internal audits, and facilitating corrective actions to address any identified issues. As part of our ISO 9001 certification, I led cross-functional teams in creating and updating standard operating procedures, ensuring that they adhered to ISO requirements. I also collaborated with our engineering team to develop a robust design control process in line with ISO 13485 for medical devices. Additionally, I utilized regulatory databases and submission software to track and manage our regulatory submissions, ensuring accuracy and completeness. By actively staying updated on the latest changes in regulations and standards, I ensured our company maintained compliance and successfully navigated regulatory inspections and audits.

Yes, I have extensive experience with Quality Management Systems (QMS) and ISO standards. In my previous role as a Senior Regulatory Specialist at XYZ Company, I played a critical role in establishing a robust QMS framework that ensured compliance with ISO 9001 and ISO 13485 standards. I led a team of regulatory professionals in developing and implementing quality processes and procedures, resulting in improved operational efficiency and cost savings. I conducted thorough audits of our QMS, identifying areas for improvement and implementing corrective actions that significantly reduced non-compliance issues. Additionally, I collaborated with cross-functional teams to create a comprehensive training program on QMS and ISO standards, equipping employees with the necessary knowledge and skills to maintain compliance. My expertise in regulatory databases and submission software allowed me to streamline submission processes, reducing response times and ensuring timely approvals. By staying abreast of regulatory changes, I successfully guided the company through multiple regulatory inspections and audits without any major findings. Overall, my deep understanding of QMS and ISO standards, coupled with my ability to effectively collaborate with teams, has consistently ensured regulatory compliance and bolstered the company's reputation for quality and reliability.