REGULATORY AFFAIRS SPECIALISTS

Intellectt Inc

Iselin, NJFull-time$124K/yrSeen todaySeen in employer's feed today

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At a glance

Compensation

$124K/yr

Location

Iselin, NJ

Schedule

Full-time

Work Authorization

Not specified

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Requirements

Credentials this posting asks for.

Bachelor's degree

Job overview

The Regulatory Affairs Specialist gathers and analyzes product information, designs and validates cGxP systems per 21 CFR Part 11, and prepares documentation for FDA compliance. Responsibilities include qualification, risk management, traceability, and submission of regulatory filings. The role requires a bachelor's degree in a scientific field and five years of related experience, working onsite in Iselin, NJ.

Skills & qualifications

RequiredNice to have

Skills

cGxP Systems21 CFR Part 11FDA RegulationsQualification ValidationRisk ManagementTraceability MatrixGMDN CodesProduct Code Analysis

Qualifications

Bachelor's DegreeFive Years Experience

Full job description

Experience Required

60 MONTHS

Minimum Education Required

BACHELOR'S DEGREE

Compensation

$124,176.00 - $124,176.00 / Yearly

Hours Per Week

Number Of Positions

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. 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: Iselin, NJ and various unanticipated locations throughout the U.S.

Email Resume to HR Dept., Intellectt, Inc., at [email protected]