VP, Quality Assurance & Regulatory Excellence

Sarnova HC, LLC; Dallas (TX); Vor Ort; USD 180.000 - 280.000; Vollzeit

Benefits dieser Stelle

401(k) Plan

Competitive benefits package

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Regulatory affairs leadership

Quality systems

FDA regulations

ISO 13485

Acquisition integration

Stakeholder management

Ausbildung

Bachelor's degree in Engineering/Life Sciences

Tools

CAPA systems

Audit management tools

Jobbeschreibung

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