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!
- 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
- 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.
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