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. Problem-solved all issues that arose related to the project.• 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 labeling, technical reviews, design reviews. • 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• Developed Standard Operating Procedures within a Quality Management System• Provided regulatory review and approval of manufacturing, R&D and quality documentation (CAPAs, NCMRs, Adverse Event reporting, quality events), and advertising and promotional material forconsistency with regulatory filings/ claims• Conduct monthly Post Market Surveillance and Regulatory Intelligence on competitor clearance/ approvals, recalls, adverse events covering Collagen Wound dressings with product codes:OXH, OXK, OWV, FTL, PAI, FTM, KGN and PSQ

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. Problem-solved all issues that arose related to the project.• 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 labeling, technical reviews, design reviews. • 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• Developed Standard Operating Procedures within a Quality Management System• Drafting and compiling FDA special 510(k) regulatory submission

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