VP, Quality Assurance & Regulatory Excellence

Sarnova HC, LLC

Dallas (TX)

On-site

USD 180,000 - 280,000

Full time

14 days+

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Benefits offered by this job

401(k) Plan

Competitive benefits package

Job summary

Sarnova HC, LLC is seeking a Vice President of Quality Assurance and Regulatory Affairs to lead quality systems and regulatory strategy as the company expands into medical device manufacturing. The role oversees design controls, CAPA, supplier quality, and post‑market surveillance across portfolios, with a hands‑on, strategic leadership approach and strong executive influence.

The successful candidate will align QA/RA with FDA and ISO standards, manage regulator interactions, and drive

Qualifications

Bachelor’s degree in a technical field; 15+ years in quality assurance and regulatory affairs in medical devices.
7+ years of progressive leadership in quality/regulatory functions.
Deep knowledge of FDA, ISO 13485, design controls, CAPA, supplier quality, and post‑market surveillance.

Responsibilities

Lead enterprise QA and regulatory affairs to support growth and patient safety.
Develop and maintain a QMS aligned with FDA ISO 13485 and MDSAP requirements.
Regulatory strategy for product approvals, registrations, labeling, and lifecycle management.
Oversee post‑market surveillance, supplier quality, audits, and remediation initiatives.
Collaborate with Product Development, Operations, Supply Chain, and Legal to integrate requirements.
Build and coach a high‑performing quality/regulatory organization and metrics.