Design Dossier Expert - Devices
Job Opportunity at Med Exec Intl / MEIRxRS

Posted on Oct 29    818-247-1368

Location: San Diego/Home, CA
Job Type: Full Time
Job ID: W4119098

(Home Based – Offices in San Diego, CA)
Roles and Responsibilities:
Assessment of active and non-active medical devices and their manufacturers per the European Medical Devices Directives, other applicable Regulatory Systems and International standards, including related client and project management
  • Perform conformity assessments of regulatory submissions to relevant safety principles and standard requirements:
    • Design Dossiers
    • Technical Documentations
  • Perform regulatory audits of clients per European Medical Device Directives (AIMD, MDD, IVDD), Canadian Medical Device Regulations (CMDR), Japanese Pharmaceutical Affairs Law (JPAL) and International quality system standards (e.g. ISO 13485)
    • Schedule and Plan
    • Review corrective actions
    • Prepare reports and audit documentation for submission to the certification committee of the Notified Body
  • Provide project management for NAFTA-based customers:
    • Issue quotes
    • Coordinate multiple projects
    • Coordinate audit team
  • Communicate with internal and external customers in all circumstances including answering questions, relaying messages, and providing information with regard to standards, regulatory and technical requirements for compliance with standards and the respective regulatory system
  • BS Degree in a science related field
    • Mechanical, biomedical, electrical or electromechanical engineering
    • Chemistry, biology or microbiology
  • Four years work experience in design / product development / manufacturing engineering in one of the following areas:
    • Active implantable medical systems
    • Sterilization (ETO, Gamma and/or liquid)
    • Medical and medicinal products (synthetic and of animal origin)
    • Ophthalmological solutions
    • Cardiovascular products
  • Sound knowledge in regulatory requirements (MDD-93/42/EEC and other related requirements)
  • Sound knowledge in product (technology, quality, etc.)
  • Some domestic and international travel
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