Employvision
Regulatory Affairs
Irvine, CA, United States
No sponsorshipDetected 3249 days ago
ComplianceFDA RegulatoryMedical DevicesCommunicationRegulatory Affairs
About the role
- All your information will be kept confidential according to EEO guidelines.
Responsibilities
- Support and participate in audits performed by internal and external (e.g., FDA, Notified Body, etc.) representatives.
- Support the implementation of regulatory activities throughout the Halyard Irvine facility.
- Provide regulatory support and review of regulatory files such as International Registrations, DMRs, Technical files, Design Dossiers, 510ks, etc.
- Perform other responsibilities, as assigned
Requirements
- Minimum of Bachelor's degree in a scientific discipline or equivalent.
- Experience Requirements
- Ability to multitask effectively and work efficiently within a strict timeline-driven environment.
- Maintain regulatory affairs files (e.g., establishment registrations and device listings, quality certificates, and device/facility licenses) and distribute information as required to support key stake-holders.
- Follow-up, track and assemble regulatory commitments to Agencies as required.
Benefits
- Ensure compliance of Technical Files contents with relevant Health Authorities requirements.
Company info
- Medical Device company
Apply directly at Employvision →Create a free account for alerts like thisView Employvision immigration profile
This listing is sourced directly from Employvision's careers page and normalized into a canonical job model.