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Director of Quality and Regulatory Affairs

San Diego, CA

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Description

RemX is currently in search for a Director of Quality & Regulatory Affairs for a top Medical Cardiovascular Product Manufacturer in San Diego.  

Salary is DOE along with benefits and great bonus plan!

Duties:

  • Director will lead a companywide Quality Assurance and Regulatory Affairs department to provide functional for a product development and commercialization. 
  • Develops the organizational / product regulatory and quality assurance strategies
  • Assures regulatory compliance and quality assurance functions required to develop accurate specifications, service, and deliver of products to our customers
  • Manages and modifies a complete and comprehensive quality system to support development and contract manufacturing of medical products in various categories including Class 1 and Class 2
  • Assures validation of compliance of contract manufacturing and sterilization facilities
  • Ensures for all duties in compliance with FDA’s Quality Systems Regulations, GMP’s, ISO13485, Canadian Medical Device Regulations, Medical Device Directive 93/42/EEC, AMMI Sterilization Standards, OSHA, EPA, and other international, federal, state, and location regulatory agencies
  • Evaluates and controls vendor reliability of goods and services
  • Manages regulatory elements of development schedules, personnel, resources and continuous improvement efforts to achieve efficient product creation and effective transfer of manufacturing
  • Prepares documentation and submits regulatory filings including 510K submissions, Device Master files, technical files, and post market surveillance
  • Conducts on site audits of various business units product and processes and host regulatory agency audits as needed
  • Provides companywide education and guidance in quality / regulatory sciences

Job Requirements

  • BS Degree or higher along with 8 plus years of related work experience with 3-5 years of recent management background
  • Must have implementation of Quality / Regulatory along with medical device product development and manufacturing experience
  • Strong understanding of geometric dimensioning / tolerancing, statistical quality concepts, and blue print reading.
  • Strong leadership skills and experience

 

Forward your resume ASAP!  Don’t miss out on this great opportunity. 

 

Key Words:

Director, Manager, Quality, Regulatory Affairs, Medical, Cardiovascular, Catheter, Life Science, ISO 13485, FDA, 510K, ISO 14971,

Product Development, AMMI, CFR, GMP, Quality Assurance, Scientific, Cardiovascular, Vice President, President, Certified Quality Engineer, Certified, AAMI

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