Position Summary
This position serves as a subject matter expert in managing FDA Medical Device Reporting (MDR) and EU Medical Device Incident Reporting (MIR) case information within the Global Complaint Management (GCM) organization. This includes: daily monitoring of the case tracker and Device Safety mailbox with triage and forward of new case data, tracking on-time regulatory reporting, communicating with vendors performing safety activities on behalf of ICU Medical, reviewing cases in ICU Medical workflow, supporting aggregate reporting activities, and participating in site audits as needed.
Essential Duties & Responsibilities
- Serve as a subject matter expert for Complaint Regulatory Reporting (MDR/MIR) within the Global Complaint Management (GCM) organization.
- Maintain case tracker and Device Safety Mailbox with triage and forward of reports as received each day.
- Track and ensure on-time regulatory submissions.
- Respond to Regulatory Agency inquiries and manage timeliness of inquiries to ensure on-time responses.
- Maintain pertinent communication with vendors performing MDR/MIR case processing including maintenance of database, reconciliation activities, and day to day input and feedback as needed.
- QC cases in Safety Database upon appearance in ICU Medical workflow.
- Complete periodic/aggregate MDR/MIR reports as assigned.
- Assist with new employee training/continuing education.
- Maintain working knowledge of complaint processing to be able to serve in back up capacity.
- Provide support for audits and work on special projects as they arise.
- May serve as operations team leader in the absence of the team manager.
- Works independently and is accountable for completing tasks as assigned. Works well in a team to accomplish team goals.
Knowledge, Skills & Qualifications
- Experience with or knowledge of medical terminology and how the drug products and medical devices are typically used in a clinical setting.
- Intermediate experience with computers and software such as Outlook, Word, Excel, PowerPoint, WebEx, TrackWise, Agile.
- Must be able to communicate effectively with internal and external customers.
- Must demonstrate critical thinking and problem-solving skills.
- Proficiency in complaint data analysis and presenting a summary to management.
Education And Experience
- Must be at least 18 years of age
- Bachelor of Science Degree in Nursing, Bio-Medical Engineering, Pharmacy, Medical Technology/ Clinical Laboratory Science, or other scientific field.
- Minimum 4 years of experience in a health care environment, and/or within a quality/compliance/regulatory organization in an FDA regulated business.
- Minimum 4 years of MDR or MIR Regulatory Report Submissions
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.
- Typically requires travel 5-10% of the time
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.
Market Surveillance
Primary Location
US-IL-Lake Forest
Schedule
Full-time
Shift
Day Job
