Regulatory Affairs Manager, Diagnostics/IVD - Remote

Overview

The Sr. Regulatory Affairs Manager is responsible for supporting the development and operations team’s compliance with FDA, CLIA, CAP, IVDR, and other global regulatory requirements, while working cross-functionally to support key regulatory submissions.

In Short

• Responsible for regulatory filings for new product introductions and expanded indications.
• Oversees submissions in multiple ex-US jurisdictions including EU and APAC.
• Develops change notification strategies for registered products.
• Contributes to agency communications regarding nonconformances or adverse events.
• Manages regulatory processes and documentation.
• Works with quality system process owners to interpret applicable regulations.
• Reviews project contracts for regulatory requirements.
• Informs the team of new or revised standards affecting IVD products.
• Must work Pacific Coast hours.
• Contract-to-hire position at a cutting-edge client.

Requirements

• Bachelor's + 12 years, Master's + 8 years, or PhD + 5 years of related experience.
• 6-8 years of regulatory experience in medical device or diagnostics companies.
• Preferred experience managing regulatory filings with the FDA and other bodies.
• Broad knowledge of post market surveillance regulations.

Benefits

• Medical, dental, vision, and telemedicine benefits.
• Retirement savings plan and service bonus.
• Paid holidays and sick leave.
• Access to various voluntary benefit plans.