Overview:
The Specialist, Post Market Quality position is responsible for working with Medical Management Solutions (MMS) on various post market quality issues, including, Supporting timely execution of field actions within North America for MMS related field actions.
This should be achieved through outstanding communication, effective problem solving and active management of ambiguous situations. The jobholder must be well knowledgeable in FDA expectations, regulatory standards, and best practices in all areas for which they are accountable.
RESPONSIBILITIES
Performs Global Regulatory Impact Assessment (GRIA) for North America and serves as coordinator to all other regions/countries for GRIA completion maintaining all regional documentation in the field action file
Assists in preparation of distribution reports as needed for field action preparation
QUALIFICATIONS:
BA or BS degree, with minimum of 1-2 years relevant experience in the medical device, in vitro diagnostics, or pharmaceutical industry.
Preferred Experience & Education:
Experience with post market surveillance and/or post market quality.
Expertise in participating in both internal and external audits.
Experience in 21CFR 806 and Canada Recall Regulations.
Experience with medical devices containing software.
Experience working within software management systems, such as, ERP and QMS systems.
please share resume at [email protected] or call me at 678-935-7045!
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