Rupal Singhal

Background

About Rupal Singhal

An accountable Medical Device Regulatory Affairs Professional with understanding of both legal and scientific matters. I help organization keep up to date by compliance with applicable national and international standards, guidelines and customer practices. As a RA Professional, I collect, analyze and coordinate information to prepare regulatory documentation and technical dossiers for submission to regulatory agencies • I work by Identifying and interpreting regulations, guidelines, standards and other pertinent information issued by applicable regulatory agencies and other associated regulatory authorities. • Review product requirements, help implement ISO standard (ISO13485) to update Quality System documents and ISO standard (ISO 14971) for risk assessment and management process • Provide input for regulatory requirements and regulatory strategies in cross-functional team on product development to ensure timely submission and approval. • Collaborate with engineers, QC/QA to create quality submissions ensuring successful review by regulatory authorities. I believe persistent Active Learning with adaptability attribute helps in the implications of new information for both current & future problem-solving and decision-making to considerable variety in the workplace.