MDR/Vigilance Specialist

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.

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

If you want to apply and want to know more, please contact:

Sagar Rathore

sagar.rathore(AT)collabera.com

630-485-2166