Regulatory Affairs Specialist
4300 Hacienda Drive Pleasanton, CA 94588
1. After introduction to organization, policies, and procedures, works independently on assigned projects under general supervision and is responsible for regulatory project and/or program management, and records of regulatory activities. Follows timelines for identified projects, and project action items.
2. Assists with the devleopment of appropriate formats for electronic documents. Assists with electronic transfers of files, and creates status reports to circulate both within the department and other company stakeholder departments.
3. Assists with regulatory projects, including international registration filings.
4. Helps with database(s)maintenance.
5. Interacts with Regulatory Affairs staff to assist in the coordination and preparation of registration filings.
6. Uses discretion and independent judgment to implement or suggest solutions for process improvements.
7. Utilize internal/cross-functional/customer relationships.
- Minimum: 2 years of design control experience in a medical device or IVD company in Development/Operations/Quality/Regulatory
- Minimum education - Bachelors in a biology related field