REGULATORY AFFAIRS SPECIALISTS
South Plainfield, NJFull-time$124K/yrSeen 4 days agoSeen in employer's feed 4 days ago
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Requirements
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Job overview
The Regulatory Affairs Specialist gathers and analyzes product and device information, including product codes, device descriptions, FDA listing numbers, and GMDN codes. The role supports cGxP systems and prepares regulatory and quality-compliance documentation for submission to authorities. It also handles qualification and validation activities, risk management, traceability, and related analyses for facilities, equipment, systems, and processes.
Skills & qualifications
Skills
Qualifications
Full job description
Experience Required
60 months
Minimum Education Required
Bachelor's
Compensation
$124,176.00 - $124,176.00 / 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 asper 21CFR Part11 & US FDA. Responsible for qualification & validation (IQ/OQ/PQ), master plans, protocols, changes requests, gap & root cause analysis, risk management plans, traceability matrix, summary reports for facilities, equipment, systems & processes. Prepare, review, authorize & submission of documentation for quality compliance & regulatory authorities. Skills required: EU MDR, ISO 13485, cGmp, IQ/OQ/PQ, MDSAP, 93/42 EEC and eCTD. Bachelor’s degree in Science, Technology, Engineering, Chemistry, Pharmacy, Biology, Health Science, or Regulatory Affairs (any) along with five (05) years of experience in the job offered or related occupation is required. Work location: South Plainfield, NJ and various unanticipated locations throughout the U.S.
Place of Work
On-site
Requisition ID
RAS259
Job Type
Full Time
Application Email
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