Christa Casey Email & Phone Number

Maryland Heights, Missouri, United States

Chesterfield, Missouri

Springfield, Missouri Area

Coordinated medical education (accredited and non-accredited) activities in Europe and U.S. for medical device and pharmaceutical companies. Medical education included live symposiums covering topics for chronic kidney disease (pharmaceutical treatments and biomarkers) and management of heart disease. Symposiums occurred within professional conferences such as Heart Failure, European Society of Cardiology, European Renal Association – European Dialysis and Transplant Association, and International Symposium on Intensive Care and Emergency Medicine.

Springfield, Missouri Area

Product Management:• Gathered and prioritized market trends and product and customer requirements through organizing focus groups, sampling professional opinions during medical meetings and leveraging feedback from the company’s Medical Advisory Board.• Coordinated and maintained product development strategies, timelines, objectives and marketing related project documentation for all products.• Managed data repositories on all supporting clinical evidence through continuous literature searches and reviews, industry reports and competitor activities.• Performed continuous market surveillance and competitor analysis. • Identified, set the strategic direction, coordinated logistics and attended key medical and industry meetings (national and local level).• Worked closely with Engineering teams to create and manage the production of all product labeling, including technical writing for the operators manual. Alternative Funding:• Researched, identified, interpreted, wrote (pre-proposals, proposals, concept papers, requests for information) and submitted proposals for government funding to agencies such as the DoD, VA and NIH.• Managed the appropriate working team(s) for each funding opportunity in gathering specific technical and clinical material for the required elements of each submission.• Co-author for awarded IRS - Qualified Therapeutic Discovery Project (QTDP) under The Patient Protection and Affordable Care Act of 2010 (PPACA).Regulatory Affairs:• Coordinated all activities related to FDA filings with internal working teams and regulatory advisors.• Assisted with defining the regulatory product roadmap and process. • Helped coordinate and prepare submission materials and subsequent interactions (face-to-face meetings, formal and informal communication to FDA) during the pre-IDE process, which included requesting and receiving expedited review.• Successfully obtained 510(k) pre-market submissions for a handheld EEG recording device (K082886).

• Supported engineering in coordinating product development by creating project plans and setting maintaining milestones. • Developed and coordinated marketing related project documents for the SNAP II product line.• Conducted all market surveillance and competitor research.• Created all product labeling including operating manuals, device and shipping labeling. • Gathered supporting clinical evidence through ongoing literature searches and reviews and presenting the evidence in the form of weekly updates to the sales and marketing associates.• Performed initial data collection on technologies, industry and market trends for new or enhanced product features. (e.g. presented findings from an investigation to support connectivity of the device outputs into hospital information systems and electronic health records) • Prepared and coordinated with legal entity and inventors for all product related trademark and patent submissions and ongoing examinations actions.