Regulatory Affairs Specialist- Medical Device - Irvine , CA | Biospace
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Regulatory Affairs Specialist- Medical Device

Lab Support, A Division Of On Assignment

Irvine , CA
Posted Date:
Position Type:
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Chemistry, Medical Device, Regulatory Affairs,

Job Description

Fast Growing Medical Device company is seeking a Regulatory Affairs Specialist to join their team!

Responsibilities (fundamental job duties):

1. Maintain regulatory affairs files (e.g. scan, print, file)

2. Research, renew and obtain State Licensing

3. Support and participate in audits performed by internal and external (e.g., FDA, Notified Body, etc) representatives.

4. Support the implementation of regulatory activities

5. Assist in preparation and execution of Field Action activities.

6. Provide regulatory support for International Registrations, DMRs, Technical files, Design Dossiers, etc.

7. Support MDR Analyst with Medical Device Reporting (MDRs) and Medical Vigilance Reporting (MDVs).



BS/MS in Science or related field

3+ years of Experience