Emily Cannon Email & Phone Number

United States

Lakewood, Colorado

My primary responsibility is to write clinical evaluation reports (CER) for new and mature products requiring a CE Mark to market them outside the US. These documents require compliance with and knowledge of the European Commission MEDDEV 2.7/1 Rev 4 and the Medical Device Regulation, as well as collaboration with quality, marketing, research and.

Austin, Texas Area

As a scientific evidence specialist, wrote CERs for new and mature products requiring a CE Mark to market them outside the US, in addition to compiling post-market surveillance plans. These documents required compliance with and knowledge of the European Commission MEDDEV 2.7.1 and MDD 93/42/EEC as well as collaboration with marketing, research and.

Austin, Texas Area

As a member of the Regulatory Affairs Department, which works closely with the R&D and marketing departments, I compiled clinical evaluation reports for the international oversight of the devices released outside the US. This involved a thorough literature review, a review of Medical Device reports, the MAUDE database and an assessment of device safety and.

Austin, Texas Area

As a clinical project manager, my primary responsibility was to write the clinical evaluation reports (CER) for new and mature products requiring a CE Mark to market them outside the US. To accomplish my job, I familiarized myself with the European Commission MEDDEV 2.7.1 and MDD 93/42/EEC guidance documents; created a literature search protocol that.

Gaithersburg, Maryland

Moved IBT from the research and development (R&D) realm into a quality systems environment. As assay development expert, taught the assay development staff the process to follow when taking an assay from R&D to a qualified assay for use in preclinical and phase I clinical trials. Provided regulatory affairs expertise.

Bethesda, Maryland

Functioned as the Division of Microbiology & Infectious Diseases (DMID), Office of Regulatory Affairs (ORA) Good Laboratory Practice (GLP) regulations and bioanalytical assay expert. Assessed assay development and qualification according to the FDA's Bioanalytical Assay Validation Guidance and ICH Guidelines for multiple Centers for the Disease Control and.

Frederick, Maryland

Provided current Good Manufacturing Practice (cGMP) Quality Assurance (QA) oversight and regulatory support within the Synagis manufacturing facility. Performed real-time QA review of the manufacturing process, from formulation of the growth media to storage of the drug substance prior to fill and finish.

Rockville, Maryland

Clinical sample coordinator and analyst for recombinant human (rhu) Endostatin and Angiostatin samples in support of INDs. Performed various immunoassays in support of preclinical research.