What are the responsibilities and job description for the Regulatory Affairs Coordinator position at Kelly Science, Engineering, Technology & Telecom?
Join Kelly FSP as a Regulatory Affairs Coordinator on site with our Medical Device client in Irvine, CA! Hybrid Position Tuesday and Thursday in office.
Job Description
Purpose
Provide support to the Regulatory Affairs department to manage Coordination of training for all Regulatory Affairs (RA) staff globally; Coordinate records maintenance; manage Purchase Orders under budget constraints; lead all administrative duties as requested.
Responsibilities .
- Responsible for ensuring personal compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance
- Provides administrative support to the RA department as directed.
- Organizes and maintains regulatory compliance documents and databases.
- Maintains database index of regulatory information regarding company products.
- Organizes, maintains and archives electronic and hard copies of submission records, certificates and other regulatory documentation.
- Assist during regulatory and supplier / distributor audits. and maintains audit files.
- Compiles compliance information, provides periodic updates on training requirements and records maintenance to department staff
provides routine and non-routine regulatory reports as requested and keeps regulatory listings current.
Qualifications
Bachelor’s degree is preferred
2 years of related experience and / or training in a regulated environment (Regulatory, Clinical or Legal)
Medical Device Regulatory Affairs experience is highly desired.
Strong Attention to details
Being organized
Quality and process improvement oriented,
Must be proficient with MS Office applications
