Regulatory Affairs Specialist in San Diego, CA at Apex Life Sciences

Date Posted: 2/12/2018

Job Snapshot

Job Description

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.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or 844-463-6178.