Specialist I, Regulatory Affairs
This position is responsible for assisting in obtaining regulatory approvals and ensuring compliance to FDA and international regulatory agency requirements including ISO, local, state and / or federal requirements. Job duties :
- Serves as a member on project teams completing tasks as assigned by the team.
- Aides in the execution of the regulatory plan for the assigned market(s) based on the approved regulatory strategy.
- Assists in preparing regulatory submissions to ensure MicroVention devices are commercially available in the assigned market(s) based on the approved regulatory strategy.
- Aides in integrating various sources of information into a uniform style and language for regulatory submissions.
- Documents, consolidates and maintains verbal and written communication with regulatory agencies.
- Maintains regulatory files and records.
- Assists in reviewing change order documents and ascertains impact on current regulatory approvals.
- Assists with technical publishing of submissions.
- Supports and contributes into editing / revising Standard Operating Procedures.
- Builds team cohesiveness by supporting team members.
- Performs other duties and responsibilities as assigned.
Regulatory Affairs Specialist
QA, R&D, Manufacturing or Project Management within the IVD industry.Working knowledge of FDA, and CE marking requirements for IVD products is a plus.Able to work independently and with others.Able to work with minimal supervision.Excellent computer applications skills.Strong customer orientation an...
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Medical Device Manufacturer in Irvine CA is looking for a Sr Regulatory Affairs Specialist to join their growing team!. This position is responsible for providing guidance on regulatory requirements as well as assisting in regulatory related projects and tasks ensuring compliance with FDA regulation...