REGULATORY AFFAIRS SPECIALISTS

Kennedy International Software Inc

Metuchen, NJFull-time$85K/yrSeen 1w agoSeen in employer's feed 3 days ago

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At a glance

Compensation

$85K/yr

Location

Metuchen, NJ

Schedule

Full-time

Work Authorization

Not specified

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Requirements

Credentials this posting asks for.

Master's degree

Job overview

The role gathers and analyzes information for product codes, device descriptions, FDA listing numbers and GMDN codes, designs, develops, tests, documents and supports cGxP systems per 21CFR Part11 and US FDA regulations using EU MDR, ISO 13485, cGMP, IQ/OQ/PQ, MDSAP, 93/42 EEC and eCTD, creates master and risk management plans, change requests, traceability matrices and summary reports, and prepares, reviews, authorizes and submits documentation for quality compliance and regulatory authorities.

Skills & qualifications

RequiredNice to have

Skills

EU MDRISO 13485cGMPIQ/OQ/PQMDSAP93/42 EECeCTD

Qualifications

Master's Degree in Science, Technology, Engineering, Chemistry, Pharmacy, Biology, Health Science, or Regulatory Affairs

Full job description

Minimum Education Required

Master's degree

Compensation

$84,781.00 - $84,781.00 / 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 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. Skills required: EU MDR, ISO 13485, cGmp, IQ/OQ/PQ, MDSAP, 93/42 EEC and eCTD. Master’s degree in Science, Technology, Engineering, Chemistry, Pharmacy, Biology, Health Science, or Regulatory Affairs (any) is required. Work location: Metuchen, NJ and various unanticipated locations throughout the U.S.