Tekwissen - Analyst, Safety Regulatory Reporting and Global Complaints - ICU Medical
3 weeks ago
- Must be at least 18 years of age.
- High School Diploma required.
- Bachelors Degree in Engineering, Medical Sciences, or other related scientific field required.
- 2+ years experience in a health care environment, and/or within a quality/compliance/regulatory organization in an FDA regulated business preferred.
- Client FDA Medical Device Reporting and experience with Trackwise Digital preferred.
- This is largely a sedentary role.
- This job operates in a professional office environment and routinely uses standard office equipment.
- The temporary position is responsible for managing device complaints and adverse events globally.
- This may include: complaint initial triage, submitting regulatory reports in accordance with applicable regulations, referring potential safety cases to applicable department, providing updates to reports, reviewing for closure/reopening as needed, and assuring timely processing of complaints.
- 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.
- Works independently and is accountable for completing task as assigned.
- Works well in a team to accomplish team goals.
- 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.
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