Regulatory Affairs
Job Description
Support regulatory compliance throughout the organization by performing the required activities that assure compliance with domestic and international regulations. Help refine and maintain systems for organizing and retrieving regulatory related information.Responsibilities
- 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.
- Participate in the review of process/product changes, labeling, complaints, etc., to determine the need for any regulatory activities and to ensure compliance to FDA, Notified Body and international requirements.
- Prepare and obtain clearance of global product submissions per their respective regulations.
- Ensure compliance of Technical Files contents with relevant Health Authorities requirements.
- Support and participate in audits performed by internal and external (e.g., FDA, Notified Body, etc.) representatives.
- Assist international sales and marketing with regulatory registration requirements.
- Support the implementation of regulatory activities throughout the Halyard Irvine facility.
- Assist in preparation and execution of Field Action activities.
- Provide regulatory support and review of regulatory files such as International Registrations, DMRs, Technical files, Design Dossiers, 510ks, etc.
- Follow-up, track and assemble regulatory commitments to Agencies as required.
- Perform other responsibilities, as assigned
Education
Requirements
- Minimum of Bachelor’s degree in a scientific discipline or equivalent.
All your information will be kept confidential according to EEO guidelines.
Experience Requirements
- 3 years’ relevant experience in Class II or Class III Medical Device Industry highly preferred.
- Exceptional written and verbal communication skills.
- Team player with excellent organizational skills.
- Ability to multitask effectively and work efficiently within a strict timeline-driven environment.
- Self-starter, able to work independently.