In my current position, I work to prepare EU MDR submissions for medical devices and build quality systems. I coordinate work in the most effective manner possible to ensure timelines are met. I develop SOPs and Quality Management Systems. Perform gap analysis to determine if documentation adheres to the regulations, legislation, or directives that are applicable. Perform audits and assist in the completion of audit reports. I strive to encourage an environment that allows for open communication and allows for high productivity. I believe it is important to stay informed and share available knowledge to drive a team building environment.

• Review and provided regulatory input changes to the design, manufacturing, labeling for impact to product approvals/submissions• Collect and organize information on regulatory requirements for quality, preclinical, clinical data to meet applicable regulations • Compilation and organization of materials for pre-submission reports and communications.• Prepare dossiers and submission packages for regulatory agencies• Maintain communication logs and outcomes relevant internal and external stakeholders.• Assistance in the scheduling of meetings with internal stakeholders and regulators.• Development and organization of materials for meetings with internal stakeholders and regulators.• Proficient implementation of domestic and international regulations in the manufacturing of medical devices.

As Senior Laboratory Technician I performed both testing and document control. I implemented new training process and updated standard operating procedures to ensure the most accurate and efficient process. I trained technicians for both the in vitro testing and cell culture. I ensured compliance with regulations for ISO 10993, OSHA, and JMHLW. As a safety officer I was certified to perform life saving acts and deal with all chemical and biological spills or contamination. I initiated and performed installation qualifications, operational qualifications, and performance qualifications to implement as well as ensure the performance of testing equipment. I ensured daily operation and functionality of the laboratories, additionally scheduling testing to ensure due dates and laboratory needs were met.