Head of QA/RA

We’re looking for an accomplished Quality & Regulatory leader to own our global QA/RA strategy and execution as we scale for commercial operations. In this role you will strengthen quality culture, transform the existing QMS framework into a high-performing, commercially supportive function, and lead global regulatory strategy.

In your first months, you’ll focus on:

Define and execute multi-year QA/RA roadmap to support sustained compliance through near term commercial scale and global expansion

Design and scale QA/RA organization, build a high-performing team

Establish effective cross-functional partnership with R&D, Operations and Commercial, and external partners

Architect legacy QMS framework into user-friendly, and scalable (eQMS) system, designed for compliance and rigor; drive continuous QMS improvement efforts to ensure on-going compliance for QMS processes throughout total product lifecycle

Plan and lead audit program to ensure internal audits, supplier audits, and external audits /inspections (Notified Body and U.S. FDA) support QMS compliance

Own global Regulatory Strategy definition and execution, including submission preparation, agency interactions, and lifecycle maintenance

Fulfill Person Responsible for Regulatory Compliance (PRRC) obligations (EU MDR)

This is what your success looks like
After 12 months you have successfully prepared the company for compliant, commercial scaling. You have helped to further establish a culture of quality throughout the company supported by a user-friendly eQMS. You have orchestrated the design transfer to production and production validation in collaboration with R&D, Production and our outsourcing partners. You have achieved regulatory approvals and/or recertification in the U.S. and EU.

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