REGULATORY AFFAIRS SPECIALISTS

PREMIER LIFE SCIENCES, LLC

South Plainfield, NJJob$85K/yrSeen 1mo agoSeen in employer's feed 2 days ago

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At a glance

Compensation

$85K/yr

Location

South Plainfield, NJ

Work Authorization

Not specified

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Requirements

Credentials this posting asks for.

Master's degree

Job overview

Regulatory Affairs Specialists at Premier Life Sciences gather and analyze product and device information, design and support cGxP systems, create risk management plans, and prepare documentation for quality compliance and regulatory submissions. Candidates must hold a Master’s degree in a relevant science field and work onsite in South Plainfield, NJ.

Skills & qualifications

RequiredNice to have

Skills

FDA Listing NumbersGMDN CodescGxP Systems21CFR Part11US FDA RegulationsEU MDRISO 13485cGMPIQ/OQ/PQMDSAP93/42 EECeCTDRisk Management PlansTraceability Matrix

Qualifications

Master's Degree

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. Master’s degree in Science, Technology, Engineering, Chemistry, Pharmacy, Biology, Health Science, or Regulatory Affairs (any) is required. Work location: South Plainfield, NJ and various unanticipated locations throughout the U.S.

Email Resume to HR Dept., Premier Life Sciences, LLC., at [email protected].