At Sole, I conducted a 510(k) feasibility assessment for a Class II device and developed Q-Sub templates and predicate comparison trackers. I also established a document control system, including a Master Document Register and Document Control SOP.
At Organogenesis Inc, I performed regulatory assessments for change controls and managed product complaints, including adverse event reports. I also developed complaint-handling work instructions and labeling review resources.
At Public Testing laboratory BVDU, I reviewed pharmaceutical laboratory reports and supported deviation investigations and CAPA activities. At Northeastern University, I developed three SOPs for a simulated Class II medical device quality management system.
