Regulatory Affairs Specialist

Katalyst HealthCares and Life Sciences

• $80K — $110K *
Irvine, CA 92620In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
6 days ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a scientific field such as biology, biochemistry, or medical technology.
  • Over 5 years of experience in Regulatory Affairs, Quality Assurance, R&D, Manufacturing, or Project Management specific to the IVD industry.
  • Familiarity with FDA and CE marking requirements for IVD products is favored.
  • Strong verbal and written communication skills are essential.
  • Comprehensive understanding of Regulatory Affairs policies and procedures is required.

Responsibilities

  • Prioritize and monitor case statuses throughout the day with timely updates.
  • Assist in IVDR labeling conversion and revisions of technical files for compliance.
  • Collaborate in weekly cross-functional meetings to ensure conversion plans are met.
  • Track changes in the monthly manufacturing schedule and monitor timelines.
  • Maintain an accurate labeling tracking log with details on product lot numbers and notifications.
  • Revise IVDR Technical Files to align with the most current templates and required attachments.
Full Job Description
Responsibilities:
  • Prioritize and monitor cases throughout the day, provide status updates as necessary.
  • Support the IVDR labeling conversion and revisions of technical files for appropriate products that are due to convert to the new IVD Regulation.
  • Work cross-functionally in weekly meetings to ensure labeling conversion follows the plan.
  • Monitor monthly manufacturing schedule, track change requests and monitor manufacturing timelines.
  • update labeling tracking log; ensuring accuracy of product lot numbers, RA regional notifications, follow-ups and product restrictions.
  • Update previous revisions of IVDR Technical Files to most current template, include necessary attachments.
Requirements:
  • Bachelor's degree in scientific field; biology, biochemistry, medical technology or similar.
  • 5+ years of experience in Reg Affairs, QA, R&D, Manufacturing, and/or Project Management within the IVD industry.
  • Knowledge of FDA, and CE marking requirements for IVD products is preferred.
  • Excellent verbal and written communication skills.
  • Thorough knowledge of policies, practices and procedures related to Regulatory Affairs.
* Ladders Estimates

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