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Assoc MDR/Vigilance Spec - Exempt
HireTalent
🇺🇸 United States
On-site
4 months ago
- SAP
- Oracle
4 months ago
Not enough detail in this posting to match
Bachelors Degree
Nice to Have:
High level of computer proficiency (e.g. Microsoft Office, SAP, Siebel, Oracle Clinical, etc.)
Previous complaint handling experience
JOB DESCRIPTION
Spotlight Call with HM:
5/15 @ 11:30am CST
Dial in by phone
+***,
Phone conference ID: 877 744 16#
Target BR: *** ***/hr
HM's Top Needs:
1. Complaint handling experience ideal (not required) or Customer Service experience
2. Health care related experience
3. Analytical thinking skills
Education Required: Bachelors Degree
Years’ Experience Required:> 1 year in Health Care, Quality, Medical device preferred
Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours/week
Work Location:
Do they need to be local to any MDT office and if so where? Prefer Mounds View
Does this person need to be on site? If so, full time or part time? In office 4 days/week
Responsibilities may include the following and other duties may be assigned.
Receive and assess product comments to determine need for complaint handling record.
Document required information in Global Complaint Handling (GCH).
Assess complaint file for missing required information. If information is missing, initiate attempts to gather information. Steps may include contacting:
our client Field Personnel
Health Care Providers
Patients or other initial reporters
Communicate with outside parties in a professional and customer-focused manner that is in following with our Mission and enhances the our client brand.
Evaluate incoming product events to determine MDR and Vigilance reporting eligibility.
Initiate, complete regulatory reports for timely submission to FDA and other regulatory bodies.
Determine if investigation is necessary. If investigation is necessary, determine:
Potential cause and contributing factors to the alleged event.
Device relationship.
If formal device investigation is necessary.
Summarize the results of any investigation.
Escalate complex issues to management.
Execute other projects as assigned.
Assoc MDR/Vigilance Spec - Exempt · HireTalent