Job Summary

A medical technology company has a current position open for a Remote Staff Regulatory Affairs Specialist in Fremont.

Core Responsibilities of this position include:

• Analyzing existing systems and procedures
• Evaluating and approving proposed changes to products and controlled documents
• Preparing for meetings with regulatory agencies and investigators

Applicants must meet the following qualifications:

• Advanced PC skills with proficiency in Microsoft office Suite, including Excel
• Bachelor's Degree (B.S or B.A) in Engineering, Science or equivalent focus is required
• 5 years of experience in an FDA regulated industry required
• 3 years of Medical Device Regulatory Affairs experience required
• Previous experience drafting regulatory submissions required
• Excellent analytical and writing skills