REGULATORY AFFAIRS SPECIALISTS
$80.6kNOVOZEN HEALTHCARE LLC
Minimum Education Required
Master's degree
Compensation
$80,600.00 - $80,600.00 / 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 or Engineering (any); Chemistry, Pharmacy, Biology, Health Science, Regulatory Affairs or any related field is required. Work location: South Plainfield, NJ and various unanticipated locations throughout the U.S.
Send Resume to HR Dept., Novozen Healthcare, LLC., View email address on click.appcast.io.
Place of Work
On-site
Requisition ID
RAS-999
Job Type
Full Time
Application Email
Vacancy posted 16 hours ago
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