Regulatory Compliance Specialist

5 days ago


San Diego, California, United States Cypress HCM Full time

Job Title: Regulatory Affairs Specialist

Job Summary: Cypress HCM is seeking a dedicated Regulatory Affairs Specialist to coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies.

Key Responsibilities:

  • Submission Coordination: Coordinate the submission and review of documents for inclusion in Design History files, ensuring compliance with regulatory requirements.
  • Technical Documentation: Draft, edit, and compile technical documentation and design dossier in support of CE mark/UKCA mark regulatory filings.
  • Post-Market Surveillance: Prepare post-market product surveillance reports, maintaining accurate records and tracking regulatory documentation.
  • EU/UK Vigilance Reports: Prepare EU/UK vigilance reports as needed, adhering to regulatory guidelines.
  • Regulatory Submissions: Prepare regulatory submissions for FDA A2F, ensuring timely and accurate completion.
  • Class II & III Medical Devices: Assist in the registration/application of Class II & III Medical Devices Licenses in Health Canada, collaborating with relevant stakeholders.
  • Regulatory Research: Research FDA, CMDR, MDR, IVDR, and UK MDR 2002 guidance documents to stay updated on regulatory requirements.
  • Labeling and Materials: Review labeling, package inserts, ad materials, and company website content to ensure compliance with FDA and CE regulatory requirements.
  • Maintenance and Updates: Maintain, track, and update regulatory documentation, including Essential Requirements Checklists and technical documentation.

Requirements:

  • Education and Experience: Bachelor's degree in a related field or equivalent, along with a minimum 6-7 years of experience in the IVD industry, specifically in 510k or CE technical file preparation and submission.
  • Skills and Abilities: Strong knowledge of medical devices regulations and terminologies, excellent written and oral communication skills, and proficiency with Microsoft Office.
  • Teamwork and Direction: Ability to manage multiple projects, prioritize tasks, and follow written and verbal direction with high accuracy.


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