Katie Scherer
Saint Paul,MN
Summary
Versatile healthcare professional who integrates 15 years of clinical experience with academic advancements in clinical research. Proven highly adaptable to a fast pace environment while independently managing heavy work load with precision and efficiency. Projects a solid communication style that establishes positive rapport with individuals.
Overview
17
17
years of professional experience
Work History
Medical Device Regulations Analyst
Advanced Clinical At Medtronic
08.2022 - 04.2024
- Submit Medical Device Reports (MDR) as required per FDA regulations on pacemakers and internal defibrillators.
- Analyze events reported from different sources to determine risk assessments and regulatory reportability.
- Ensure proper documentation of complaint investigations, including following up with internal and external customers.
- Submit vigilance reports as required per internal procedures and international regulations.
- Monitor and manage complaint handling processes, escalating to management as appropriate.
Post Market Analyst
Actalent Services At Abbott Labs
08.2021 - 03.2022
- Initiated and managed the complaint files for disposable cardiac pressure wire devices and catheters.
- Managed high volume complaint files with accurate entry of information in the database.
- Was responsible for independently assessing the complaint to determine if a medical device report needs to be filed with various global regulatory agencies (e.g. FDA, ECA) and submitted reports within required time frames.
- Communicated to field representatives regarding information needed specific to product complaints (e.g. physicians, hospital personnel, sales representatives, international offices)
- Complied with US FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
Registered Respiratory Therapist
Park Nicollet, Pulmonary and Sleep Clinic
12.2016 - 09.2020
- Autonomously performed technical Pulmonary Function Tests.
- Successfully completed training to become proficient in advanced Cardiopulmonary Exercise Tests (CPX) in under 6 months.
- Implemented and designed a plan to comply with Joint Commission regulations of maintaining unobstructed egress hallways.
Registered Respiratory Therapist
Hennepin Healthcare
01.2007 - 12.2016
- Coordinated with physicians and staff on care and treatments.
- Diligently documented therapies and interventions in EPIC electronic health records.
- Managed and operated mechanical ventilators in a diverse population with a large variety of medical conditions.
- Participated in the Lean Team Project and reconstruction of department supply storage to the Kanban System.
Education
Master of Science - Clinical Research
Ohio State University
Columbus, OH05-2021
Bachelor of Science - Respiratory Therapy
The College of St. Catherine
St. Paul, MN05-2008
Skills
- Writing
- Organization
- Medical Terminology
- Process and Quality Improvement
- Communications
- Problem Resolution
- Relationship Development
- Adaptable to Acute Change
- Dependable
- Autonomous
Timeline
Medical Device Regulations Analyst
Advanced Clinical At Medtronic
08.2022 - 04.2024
Post Market Analyst
Actalent Services At Abbott Labs
08.2021 - 03.2022
Registered Respiratory Therapist
Park Nicollet, Pulmonary and Sleep Clinic
12.2016 - 09.2020
Registered Respiratory Therapist
Hennepin Healthcare
01.2007 - 12.2016
Master of Science - Clinical Research
Ohio State University
Bachelor of Science - Respiratory Therapy
The College of St. Catherine
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