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!
Contract W2 Only
Position Summary The Facility Maintenance Custodian is responsible for maintaining a clean, safe, and organized work environment across all shared spaces at the Clio plant. This includes daily and scheduled deep cleaning of locker rooms, restrooms, employee break rooms...
...Registered Nurse (RN) - Labor & Delivery The RN advocates and utilizes the nursing process in the care of all age populations along the health continuum. The nursing process includes assessment, diagnosis, planning, implementation and evaluation derived from scientific...
...Job Title: Mainframe Developer with IMS and CICS Location : Jersey City, NJ/Plano, TX Duration: Long Term contract Required Skills: Programming Languages: Strong proficiency in COBOL Mainframe Operating Systems: In-depth knowledge of z/OS Database...
...Job Description We are seeking a highly skilled Senior Software Engineer to develop innovative software solutions that automate product manufacturing, laboratory testing, SQL data storage, and data analysis in a dynamic, customer-focused automotive environment. Responsibilities...
In-House Director of Litigation, Southern Florida If you are an experienced commercial litigator seeking a litigation strategy and analysis role that offers sophisticated work and allows you to advance your career goals while feeding your sense of adventure, come join...