Regulatory Affairs Specialist

San Diego, California
Feb 15, 2018
Required Education
Bachelors Degree
Position Type
Full time


Our client, an autoimmune disease diagnostics company is seeking a Regulatory Affairs Specialist to join their team. This is a DIRECT HIRE position.

Key Accountabilities

  • 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.
  • Provide support in 510(k) submissions if needed.
  • Communicates with and fulfill requests from Werfen affiliates and Inova distributors in response to needed documentation to support international regulatory registrations.
  • Prepares and coordinates documentation necessary to obtain/renew import/export licenses and related permits.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Min Knowledge & Experience

  • Bachelor's degree B.A. or B.S. or equivalent in the biological sciences or related sciences require
  • Minimum of 5 years of relevant experience within Regulatory Affairs Discipline preferably in the vitro diagnostics industry. 
  • Competent in Class II device US regulations (Required
  • Knowledge of US and International medical device regulatory requirements.
  • Demonstrated experience with ISO and QSRs as applicable to medical devices.
  • Experience in creating and maintaining EU Technical files.
  • Experience  with 510(k) submissions
  • Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.