Experienced Sr. Regulatory Affairs Specialist with a proven track record in project management and a distinguished PMP certification. Demonstrated expertise in efficiently managing pre- and post-market activities while ensuring strict compliance with regulations. Proficient in handling adverse event reporting, expertly managing complaints, and conducting meticulous regulatory assessments. Skilled in developing and executing global submission strategies, including expertise in EU MDR and FDA requirements. Collaborates seamlessly with cross-functional teams and provides invaluable regulatory guidance to senior management. Recognized for creating impactful SOPs, leading successful labeling projects, and implementing cost-saving process optimization initiatives. Passionate about making a lasting impact in the ever-evolving medical device industry.