Kalkidan (Kal) A. Molla Email & Phone Number

Washington, DC, US

Silver Spring, MD, US

Silver Spring, MD, US

Abbott Park, Illinois, US

Abbott Park, Illinois, US

• Prepares data for Clinical Evaluation Reports (CERs).
• Fulfills ad-hoc data requests from R & D, Quality, Regulatory and other related departments.
• Prepares Postmarket data for CAT, CMEMS and NMD product families into 5000 trends by failure mode every month using Business Objects (Web intelligence) and Excel automation techniques.
• Supports 10 monthly Quality Data Review meetings providing Product Experience data and understanding of the data process.
• Prepares data related trainings for quality teams (QE, PPG, PPE).
• Manages communications across different teams to fulfill their data needs.

Minneapolis, MN, US

• Electronically process events to determine complaint and reportability status. Complete applicable Medical Device Reports (MDR) as required per internal policy & procedures and FDA regulations. Ensure complaint.
• Perform tasks to obtain adequate information to ensure proper documentation and closure of each complaint.
• Collaborate with appropriate technical, Clinical, Field/Sales and/or returned product analysis employees to determine reporting eligibility.
• Support internal systems, methods, and procedures to maintain compliance.
• Develop and maintain product knowledge of CRHF products.
• Assist in inspection support for FDA and global regulatory agencies. This may include research and preparation of correspondence in response to global regulatory agencies requests for additional information.

St. Paul, Minnesota, US

• Communicated verbally and in writing both internally and externally to field representatives regarding information needed specific to product complaints (e.g. physicians, hospital personnel, sales representatives.
• Assessed the complaint to determine if a medical device report needs to be filed with various global regulatory agencies (e.g., FDA, European Competent Authorities) and sends reports within required timeframes.
• Supported all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complied with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments

Minneapolis, Minnesota, US

• I Worked on:
• Development of a Low-Cost Electron Paramagnetic Resonance (EPR) Spectrometer to Measure Properties and Heating of Iron-Oxide NanoparticlesAnd Related topics like:
• Thermal Cancer Therapy with Magnetic Nanoparticles
• MPI (Magnetic Particle Imaging)

Minneapolis And St. Paul, Minnesota, US

• My Responsibilities were:
• Coordinating Community Based Clinical Research
• Data Collection for Behavioral Health Studies
• Data Analysis
• Designing Research Projects
• Conducting Interviews with Subjects

Organizational Leadership, Leadership Readiness Program (Lrp)

Master Of Science - Ms, Mechanical Engineering

Graduate Certificate, Medical Device Development

Bachelor'S Degree In Physics

Physics

Medicine