Simone Abramczyk Email & Phone Number

Princeton, New Jersey, US

• Authored Traditional 510(k), MicroMatrix Flex (K230980), and Special 510ks, K241706 and K241724.
• Lead Regulatory team member for EU MDR submission for Class IIb products.
• Completed Regulatory Impact Assessments for various types of changes
• Drafted and submitted Change Notifications to European Union Notified Body
• Spearheaded label improvement project from initiation through validation. Developed a label creation Standard Operating Procedure and coordinated six departments for the collaboration and approval of new labels..
• Participated as a core team member in a cross-functional team in product development projects through completing design control activities. These responsibilities included, drafting and review of protocols and.

Columbia, Maryland, US

• Spearheaded label improvement project from initiation through validation. Developed a label creation Standard Operating Procedure and coordinated six departments for the collaboration and approval of new labels..
• Participated as a core team member in a cross-functional team in two product development projects through completing design control activities. These responsibilities included, drafting and review of protocols and.
• Coordinated initial international regulatory submission in Egypt.
• Organized license amendment and license renewal submissions for products sold in Canada.
• Initiated and executed change control regarding labeling changes through design controls
• Developed and edited labeling materials through document control

College Park, MD, US

• Coordinate and schedule all 75 Clark School Ambassadors for Clark School of Engineering- specific events, University of Maryland campus- wide events, and outreach events off-campus.
• Manage and execute tours for high school classes and prospective students.
• Email and communicate with Dean and Associate Dean of Engineering to coordinate major events.

Glen Burnie, MD, US

• Lead and train employees, problem solve customer related complaints, ensure customer satisfaction, collaborate with others, and volunteer and organize community outreach activities.
• Awarded Teammate of the Month, March 2017

Supervise and organize employees to ensure peak efficiency, performed initial interview for prospective employees, cross- trained in all other restaurant positions.

• Researched and mapped global diseases, wrote summaries of collected data for monthly brochure for clients, and collaboratively worked in a team to generate sound research.

• Performed several lab duties, including, cell culture, biochemical assay, collecting data, performing data analysis, and presented research in poster session.

Master Of Science - Ms, Biomedical/Medical Engineering

Bachelor Of Science - Bs, Bioengineering