REGULATORY AFFAIRS SPECIALIST

Shoolin Inc

Metuchen, NJFull-time$85K/yrSeen todaySeen in employer's feed today

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At a glance

Compensation

$85K/yr

Location

Metuchen, NJ

Schedule

Full-time

Work Authorization

Not specified

Olive lists jobs from US employers, including remote roles you can work from the United States.

Requirements

Credentials this posting asks for.

Master's degree

Job overview

Shoolin Inc seeks a Regulatory Affairs Specialist to gather and analyze product and device information, support cGxP systems, and prepare regulatory and quality-compliance documentation. The role involves work with FDA and EU regulatory frameworks and standards, including EU MDR, ISO 13485, and eCTD. A master’s degree in one of the listed fields is required. The worksite is in Metuchen, New Jersey, with additional unanticipated U.S. locations.

Skills & qualifications

RequiredNice to have

Skills

Product Code AnalysisDevice Description AnalysisFDA Listing NumbersGMDN CodescGxP Systems21 CFR Part 11US FDA RegulationsEU MDRISO 13485cGMPIQ/OQ/PQMDSAP93/42 EECeCTDRisk Management PlansChange RequestsTraceability MatricesRegulatory DocumentationQuality Compliance

Qualifications

Master's in Listed Field

Full job description

Minimum Education Required

Masters

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, Regulatory Affairs (any) is required. Work location: Metuchen, NJ and various unanticipated locations throughout the U.S.

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