International Regulatory Specialist - IVD

Location: San Diego Salary: US$75000 - US$85000 per annum + bonus
Sector: Medical Devices, Regulatory Affairs (RA) Type: Permanent

* Candidates must have at minimum 2 years of relevant industry experience within CE Mark and International Registrations *

About the Company:

  • A privately held company headquartered in San Diego, California.
  • Over 360 team members around the world.
  • Leaders in the development and commercialization of new autoimmune technologies and diagnostic markers.
  • We manufacture IVD systems and reagents that are used in clinical laboratories and hospitals around the world.

Day to day responsibilities:

  • Prepare submissions to EU regulatory entities to obtain CE Mark. Create and maintain product EU Technical Files.
  • Reviews design history files, device history records and any documentation associated with the development and/or enhancement of product, or requests from appropriate department as needed additional technical documentation, to create/maintain Technical Files and support regulatory filings and CE mark submissions and updates.
  • Create and maintain regulatory database.
  • Prepare, collect or coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners.
  • Review product labeling, advertising and marketing material for appropriateness and compliance to regulatory requirements and laws.
  • Review product changes to impact on regulatory filings worldwide.

Background requirements:

  • Bachelor's degree with at least 2 years of relevant industry experience within Regulatory Affairs.
  • Competent in Class II device required.
  • Knowledge of International medical device regulatory requirements required.
  • Demonstrated experience with ISO and QSRs as applicable to medical devices preferred
  • Broad Knowledge in Microsoft tools like Excel, Word, PowerPoint preferred.
  • Experience in creating and maintaining EU Technical files.

Sthree US is acting as an Employment Agency in relation to this vacancy.