Regulatory Affairs Associate
Current• Developed and optimized corporate processes and Standard Operating Procedures (SOPs) to enhance efficiency in cross-functional tasks requiring collaboration among multiple departments.• Engaged in comprehensive post-market surveillance activities, including Medical Device Incident Reporting (MIR) and Medical Device Reports (MDR) submissions, effectively managing adverse event reports, PMS reports, labeling updates, and Corrective and Preventive Action (CAPA) initiatives.• Facilitated the collection of essential documents for internal and external audits, ensuring seamless compliance with regulatory standards.• Oversaw the company's regulatory document control system, meticulously maintaining accuracy and adherence to regulatory requirements.• Assisted in the preparation and submission of complex regulatory applications, including FDA 510(k), Pre-market Approval (PMA), Add-to-File, and Emergency Use Authorization (EUA) applications for in-vitro diagnostic assays, resulting in expeditious market approvals.• Spearheaded the implementation of an advanced electronic document management system, optimizing regulatory document control processes for enhanced efficiency and accuracy.• Played a pivotal role in regulatory intelligence efforts by monitoring and analyzing dynamic regulatory changes and evaluating their potential impact on the company's diverse product portfolio.• Fostered cross-functional collaboration by partnering closely with Research and Development (R&D), Quality Assurance, Marketing, Sales, and Manufacturing teams, seamlessly integrating regulatory considerations into product development lifecycles.• Initiated and led comprehensive regulatory training programs, equipping the team with up-to-date knowledge, and understanding of evolving regulatory guidelines and best practices.• Collaborated effectively with international distributors to ensure strict compliance with local regulations, expediting product registrations in key global markets.
