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Director of Regulatory Affairs/Quality Assurance

Company Name: Life Science Outsourcing, Inc.
Location: Brea, CA
Job Type: Full time
Contact Name: Sylvia Armenta
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Web:  www.mpsmedical-inc.com


Job Description

MPS Medical, Inc. (www.mpsmedical-inc.com) is in North Orange County in the city of Brea, California has an immediate opening for RA/QA Director. The RA/QA Director plays a significant and strategic role in the success of MPS Medical’s ability to obtain and maintain market clearances for new and existing products.  This person is responsible for managing and preparing worldwide regulatory medical device submissions, managing quality assurance activities, managing the daily activities of the Document Control group and directing the activities of Quality Control.  The Director is the Quality Management Representative responsible for conformance with ISO 13485, QSR, CMDR, and any other worldwide quality management system requirements.



Job Requirements 

  • Responsible for the supervision, overall direction and management of Regulatory Affairs, Quality Assurance, Quality Control and Document Control
  • Responsible for the submission of 510(k)s, preparation and maintenance of Technical Files and submission of any other documentation required for other OUS markets
  • Oversee and/or perform internal and supplier audits
  • Actively address all product complaints and file MDRs/MPRs/vigilance submissions
  • Prepare test protocols and test reports, including IQs, OQs and PQs
  • Conduct training to quality policy, QSRs, ISO 13485, MDD, CMDR and other regulations Drive the design control process and risk management system 

Education and/or Experience

  • Bachelor’s degree in Life Sciences or Engineering
  • Minimum 5 years RA and/or QA management, with minimum 10 years RA/QA experience in medical devices
  • Experience in all aspects of Regulatory Affairs (510(k), IDE, establishment registration, CDPH manufacturer licensing, CE marking, Canadian medical device licensing, other international filings, etc.)
  • Experience in all aspects of Quality Assurance (QSR, ISO 13485, CMDR, auditing, complaint handling, eMDR/MPR/vigilance, ISO assessments, FDA inspections, design controls, risk management, sterilization validation, process and production validation, etc.)
  • Documented auditor training

 

* Please in your cover letter describe how your past experience matches the requirements.

* Please provide past salary history or your current salary requirements for consideration.