Job Details

Regulatory Affairs Specialist (IVDR)

Location: Irvine, CA. (HYBRID T/TH 3rd day of choice )

12 Month Assignment (Potential to Extend)

Pay rate $45–$50/hr. DOE

On behalf of our client a medical device company we are seeking for a Regulatory Affairs Specialist to support in their transition efforts for the EU's In Vitro Diagnostic Regulation (IVDR). This role will play a critical part in ensuring all CE-marked IVD products comply with the latest regulatory requirements. The position involves technical file preparation, labeling updates, regulatory notifications, and cross-functional project coordination.

Main Responsibilities:

• Ensure technical files clearly describe product characteristics, performance claims, and evidence of conformity.
• Compile required documentation (e.g., validation reports, test data) into each technical file per the defined table of contents.
• Support the IVDR labeling conversion project in collaboration with cross-functional teams.
• Update the labeling conversion tracking log using manufacturing schedules, fill dates, lot numbers, and change request information.
• Modify labeling specifications as needed to meet IVDR standards.
• Product De-Certification Support
• Assist with the process of un-CE marking selected products.
• Ensure all associated labels reflect the removal of the CE mark according to defined specifications.
• Maintain technical file and labeling tracking logs.
• Coordinate regional regulatory notifications and document changes appropriately.

Qualifications:

• Bachelor's degree in Biochemistry, Biology, Medical Technology, or related field.
• 3+years of experience in Regulatory Affairs, Quality Assurance, R&D, Manufacturing, or Project Management within the IVD industry.
• Working knowledge of FDA and CE marking requirements is highly desirable.
• Proficient in Microsoft Office and regulatory documentation systems.

Please submit a copy of your resume in Word or PDF format to be considered.