Kamil Makhnejia

Vice President Clinical Development @Jackson Medical

Atlanta, GA, US

Visit email i•••@jackson-medical.com, or call (67••••••54 for more information on Jackson Medical and GloShield.Clinical Development/Sales: Identify clinical needs and plan value-added activities in the clinical/surgical environment. Interface and discuss opportunities with healthcare decision-makers as a representative of Jackson Medical. Assess Jackson Medical\'s product lines in the trial phase and post-launch. Participate in the selling, training, servicing, and support of Jackson Medical products.Product Development: Design and developed GloShield from concept through many iterations to a commercial product. Planned project with major developmental milestones. Created and maintained Design History File, Device Master Record, Device History Record and other project-specific documentation.Quality/Regulatory: Designed and implemented Quality Management System specific to Jackson Medical\'s needs. Responsible for QA, including incoming acceptance inspections of product. Maintained regulatory filing with FDA and identify regulatory pathways/strategies for OUS.Manufacturing: Coordinated design transfer to contract manufacturers. Evaluated, selected, and approved suppliers for Jackson Medical. Represented Jackson Medical for tooling/process validation input and sign-offs. Point-of-contact on behalf of Jackson Medical for production runs.Business/Operations: Responsible for day-to-day operations at Jackson Medical. Identify and evaluate alternate sales/partnership channels to strengthen the business. Provide input for marketing and public relations. Maintain and promote the brand. Customer service, order management, and distribution of finished goods.

Georgia Institute of Technology

Master's Degree

Boston University

Bachelor's degree