VP of Quality Assurance & Regulatory Strategy

Sarnova HC, LLC; Clearwater (FL); On-site; USD 180,000 - 280,000; Full time

Job summary

Sarnova HC, LLC in Clearwater, FL seeks a Vice President, Quality Assurance and Regulatory Affairs to design and scale quality systems as the company expands from distributor to medical device manufacturing.

The role leads QMS development, regulatory strategy, post-market surveillance, supplier quality, and lifecycle compliance across manufactured, private‑label, and acquired products, partnering with senior leaders to protect patients and growth.

Qualifications

• Bachelor's degree in Engineering or life sciences with regulatory focus.
• 15+ years in quality assurance and regulatory affairs in medical devices or regulated manufacturing.
• 7+ years in progressive leadership of QA/RA functions.

Responsibilities

• Lead enterprise QA and RA functions to support growth and patient safety.
• Develop and maintain a QMS aligned with FDA, ISO 13485, and MDSAP.
• Strategize regulatory submissions and product registrations, including 510(k).
• Oversee post‑market surveillance, CAPA, audits, and supplier quality.
• Partner with product, operations, and legal teams to embed quality across lifecycles.
• Build and develop a high‑performing quality organization with budgeting and succession.

Skills

Quality leadership

Regulatory affairs

FDA regulations

ISO 13485

CAPA processes

Audits & inspections

Cross-functional leadership

Education

Bachelor's degree in Engineering

Advanced degree preferred

Job description

Sarnova HC, LLC in Clearwater, FL seeks a Vice President, Quality Assurance and Regulatory Affairs to design and scale quality systems as the company expands from distributor to medical device manufacturing.

The role leads QMS development, regulatory strategy, post-market surveillance, supplier quality, and lifecycle compliance across manufactured, private‑label, and acquired products, partnering with senior leaders to protect patients and growth.