Senior Regulatory Manager, Quality - Remote

Overview

The Senior Regulatory Manager plays a key role in leading regulatory strategy and ensuring compliance across our diverse product ecosystem, supporting regulatory operations spanning FDA, FTC, Health Canada, CFIA, CLIA, and other relevant frameworks.

In Short

• Lead and mentor the Regulatory team.
• Oversee regulatory operations and readiness for audits.
• Manage regulatory registrations and supplier qualifications.
• Collaborate on product labeling and marketing claims.
• Work cross-functionally to anticipate regulatory changes.
• Provide regulatory oversight for diagnostic laboratories.
• Monitor and report on regulatory KPIs.

Requirements

• 10+ years of regulatory compliance experience.
• Deep knowledge of U.S. and Canadian regulations.
• Familiarity with FDA, Health Canada, CFIA, CLIA, FTC.
• Experience with cGMP and NSF 455-2 requirements.
• Exceptional leadership and communication skills.

Benefits

• Market competitive compensation package including equity.
• 401K matching (within US) / RRSP matching (within CAD).
• Flexible PTO policy.
• Flexible benefits package and additional perks.
• Employee discount on Fullscript catalog of products.
• Ability to Work Wherever You Work Well.