Production Scheduler
collabera2
Full time
MDR/Vigilance Specialist
About this role
Company Description
Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs.
Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence.
Job Description
Position Responsibilities:
• Electronically process events to determine
complaint and reportability status. Complete applicable Medical Device Reports
(MDR) as required per internal policy & procedures and FDA regulations.
• Ensure complaint investigations are adequate,
accurate, detailed and timely.
• Perform tasks to obtain adequate information
to ensure proper documentation and closure of each complaint.
• Collaborate with appropriate technical,
Clinical, Field/Sales and/or returned product analysis employees to determine reporting
eligibility.
• Complete electronic submission of MDRs to the
FDA.
• Ensure accurate data entry, scanning, and
retention of documents to complete event files.
• Support internal systems, methods, and
procedures to maintain compliance.
• Develop and maintain product knowledge of CRHF
products.
• Assist in inspection support for FDA and
global regulatory agencies. This may include research and preparation of
correspondence in response to global regulatory agencies requests for
additional information.
• Develop and maintain a working knowledge of
regulations and standards related to post-market quality & complaint
handling.
• Complete projects as assigned and required
specific to post-market quality and complaint handling.
Qualifications
Basic Qualification:
Education Required: Bachelor's Degree
Years Of Experience: Less than one year experience in a health, clinical,
technical, or scientific field with a Bachelor’s Degree
Additional Information
If you want to apply and want to know more, please contact:
Sagar Rathore
sagar.rathore(AT)collabera.com
630-485-2166
Frequently Asked Questions
Is the salary disclosed for the MDR/Vigilance Specialist position at collabera2?
The salary for this MDR/Vigilance Specialist role at collabera2 is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the MDR/Vigilance Specialist position at collabera2 located?
This MDR/Vigilance Specialist role at collabera2 is based in MN, Mounds View, Mounds View, MN, United States, us. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the MDR/Vigilance Specialist role at collabera2 full-time or part-time?
This is listed as a Full time position. It is posted as a MDR/Vigilance Specialist role at collabera2.
How do I apply for the MDR/Vigilance Specialist position at collabera2?
Click the "Apply Now" button on this page. You will be redirected to collabera2's official application portal hosted on smartrecruiters where you can submit your application directly.
When was the MDR/Vigilance Specialist job at collabera2 posted?
This MDR/Vigilance Specialist position at collabera2 was posted on Dec 14, 2016. Apply as soon as possible — early applications are often reviewed first.
MDR/Vigilance Specialist
collabera2
You'll be redirected to collabera2's official application page on SmartRecruiters.