Melissa I.
Regulatory Affairs Professional
- Role
- Regulatory Affairs Manager - Hazardous Drug Solutions at BD
- Location
- Cincinnati, OH, US
- LinkedIn followers
- 500 followers
About Melissa I.
Compliance driven and goal oriented Regulatory Affairs Professional with 10+ years of cross-functional experience across Quality, Regulatory Compliance, R&D, and Supply Chain. Proven track record in developing and executing global regulatory strategies for new and existing products, including FDA 510(k) submissions, EU MDD/MDR Technical Documentation (Class EC Certificate renewals, and international registrations.Dedicated to driving continuous process improvements by applying process engineering principles and leveraging broad cross-functional expertise to promote operational excellence. Recognized for pioneering innovative solutions, exceeding expectations, and demonstrating exceptional adaptability to new teams, projects, and products.
Experience
Regulatory Affairs Manager - Hazardous Drug Solutions
Jul 2025 — Present · San Diego, US
Portfolio Lead
Education
Northeastern University
Master of Science (M.S.), Regulatory Affairs for Drugs, Biologics, and Medical Devices
Drexel University
Bachelor of Science (BS), Chemical and Biomolecular Engineering
University of Nebraska-Lincoln
High School Diploma, Independent Study Program, Early Graduation
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