Experience Required
0
Minimum Education Required
Master's Degree
Compensation
$84,781.00 - $84,781.00 / Yearly
Hours Per Week
40
Number Of Positions
5
Shift
First Shift (Day)
Job Description
Gather and analyze information for product codes, device description, FDA listing numbers and GMDN codes. Design, develop, test, document & support of cGxP systems as per 21CFR Part11 & US FDA using EU MDR, ISO 13485, cGmp, IQ/OQ/PQ, MDSAP, 93/42 EEC and eCTD. Create master and risk management plans, changes requests, traceability matrix, and summary reports. Prepare, review, authorize & submit documentation for quality compliance & regulatory authorities. Master’s degree in Science, Technology, Engineering, Chemistry, Pharmacy, Biology, Health Science, or Regulatory Affairs (any) is required. Work location: Iselin, NJ and various unanticipated locations throughout the U.S.
Email Resume to HR Dept., Intellectt, Inc., at
Place of Work
On-site
Requisition ID
RAS_901
Job Type
Full Time