Job Title
Analyst I, Global Complaint Management & Safety Regulatory Reporting
FLSA Status
Exempt
Position Summary
The position is responsible for managing device or pharmaceutical complaints and adverse events globally. Duties may include the following : initial triage of complaint files, assessments of reportability, escalating customer advocacy events, submitting regulatory reports in accordance with applicable regulations, referring potential safety cases to applicable department, obtaining additional information for events, providing updates to reports, and assuring timely processing of complaint files with regards to regulatory reporting.
Essential Duties & Responsibilities
- Responsible for evaluating complaints from patient safety perspective and completing regulatory reporting decisions per reporting requirements globally.
- Responsible for creating and submitting regulatory reports to the FDA and / or Regional Competent Authority.
- Responsible for obtaining additional information for events as needed.
- Responsible for escalating and / or assisting with customer advocacy issues as they occur.
- Manages the complaint through life-cycle from registration, sample retrieval, follow-up, investigation and closure when required.
- Provide appropriate accurate information to customers during information gathering processes and within replies. (verbal and / or written)
- Works independently and is accountable for completing task as assigned. Works well in a team to accomplish team goals.
- Work on special projects as they arise.
Knowledge, Skills & Qualifications
- Experience with or knowledge of medical terminology and how medical / pharmaceutical products are typically used in a clinical setting.
- Basic computer and software skills.
- Must be able to communicate effectively with internal and external customers.
- Demonstrate ability to collect, analyze and interpret complaint and adverse event information.
Education and Experience
- Required : Bachelor of Science Degree in Nursing, Bio-Medical Engineering, Pharmacy, Medical Technology / Clinical Laboratory Science, or other scientific field.
- Preferred : Minimum 1 year of experience in a health care environment, and / or within a quality / compliance / regulatory organization in an FDA regulated business.
Minimum Qualifications
Must be at least 18 years of age
Travel Requirements
Typically requires travel 0-10% of the time
Physical Requirements and Work Environment
- This is largely a sedentary role.
- This job operates in a professional office environment and routinely uses standard office equipment.
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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The position is responsible for managing device or pharmaceutical complaints and adverse events globally. Responsible for evaluating complaints from patient safety perspective and completing regulatory reporting decisions per reporting requirements globally. ...
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