REGULATORY AFFAIRS SPECIALISTS
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At a glance
Requirements
Credentials this posting asks for.
Job overview
The Regulatory Affairs Specialist gathers and analyzes product information, designs and validates cGxP systems, prepares and submits regulatory documentation, and conducts risk and gap analyses to ensure FDA and international compliance. They also manage qualification protocols, master plans, and traceability matrices for equipment and processes across multiple sites.
Skills & qualifications
Skills
Qualifications
Full job description
Experience Required
5 Years
Minimum Education Required
Bachelor’s degree
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 as per 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. Skill 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 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.
Email Resume to HR Dept., Novozen Healthcare, LLC., at [email protected].
Place of Work
On-site
Requisition ID
RAS-455
Job Type
Full Time
Application Email
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