VP, Quality & Regulatory Excellence — Medical Devices

Sarnova; Dublin (OH); On-site; USD 180,000 - 280,000; Full time

Benefits offered by this job

401(k) Plan

Job summary

Sarnova is seeking a Vice President of Quality Assurance and Regulatory Affairs to lead the company’s quality and regulatory strategy as it expands into medical device manufacturing. This executive will build a scalable QMS, regulatory capabilities, and audit readiness across product portfolios and acquisitions.

The role requires deep medical device QMS and regulatory experience, strong business judgment, and the ability to integrate operations while protecting patients and the company’s

Qualifications

• Bachelor’s degree in a technical field required; advanced degree preferred.
• 15+ years in quality assurance/regulatory affairs in regulated manufacturing.
• 7+ years leading quality/regulatory functions.
• Extensive knowledge of FDA, ISO 13485, CAPA, audits, post-market surveillance.
• Experience with 510(k) submissions and international regulatory requirements.
• Experience integrating acquisitions and building scalable QMS.

Responsibilities

• Lead the enterprise QA and Regulatory Affairs function to support growth.
• Develop and maintain QMS aligned with FDA/ISO13485/MDSAP and regulatory requirements.
• Serve as primary QA/regulatory representative with regulators, auditors, customers, and partners.
• Lead manufacturing quality programs: production controls, process validation, CAPA, supplier quality.
• Develop regulatory strategies for product approvals, registrations, and lifecycle management.
• Partner with cross-functional teams to integrate quality and regulatory requirements.

Skills

Strategic leadership

Regulatory affairs

Quality management

FDA/ISO knowledge

Stakeholder management

Education

Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, Quality

Advanced degree preferred

Job description

Sarnova is seeking a Vice President of Quality Assurance and Regulatory Affairs to lead the company’s quality and regulatory strategy as it expands into medical device manufacturing. This executive will build a scalable QMS, regulatory capabilities, and audit readiness across product portfolios and acquisitions.

The role requires deep medical device QMS and regulatory experience, strong business judgment, and the ability to integrate operations while protecting patients and the company’s