Quality & Regulatory Director

FloodGate Medical • Tampa, FL

2d • Onsite

About The Position

Nuwellis is a medical device company dedicated to changing the lives of patients suffering from fluid overload with its Aquadex SmartFlow ultrafiltration therapy. They focus their efforts on understanding and meeting the critical needs associated with the treatment of fluid overload. As a global leader, they strive to make it easier for healthcare providers to quickly and gently restore fluid balance in all patients, in all settings, around the globe. Their patients are at the center of everything they do. We're looking for a Quality & Regulatory Director to lead our Quality & Regulatory function and serve as our subject matter expert for FDA compliance and Quality Systems. Reporting to senior leadership, this position is responsible for maintaining an effective Quality Management System (QMS), ensuring regulatory compliance, supporting new product development activities, and driving continuous quality improvement across the organization. This is a hands-on player-coach leadership role that combines strategic oversight with direct execution. The successful candidate will lead and develop a small Quality & Regulatory team while remaining actively involved in audits, regulatory submissions, CAPA activities, supplier quality management, and day-to-day quality system operations. As Nuwellis utilizes an outsourced manufacturing model, this role will work closely with our local contract manufacturing partners to ensure product quality, regulatory compliance, and operational excellence. This position requires prior experience in the medical device industry, extensive knowledge of FDA Quality Management System requirements (QMSR), ISO 13485, and related device regulations as well as significant experience overseeing contract manufacturers within a regulated environment. This is a full-time onsite position based in Eden Prairie, Minnesota.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related technical discipline (Bachelor's degree required, but flexible on field).
• 8-10+ years of Quality and/or Regulatory experience within the medical device industry.
• Significant experience with FDA Quality System requirements and ISO 13485/ISO 14971.
• Demonstrated experience managing Quality Systems within an outsourced or contract manufacturing environment.
• Experience qualifying, auditing, and managing contract manufacturers and critical suppliers.
• Proven experience leading regulatory inspections, quality audits, and compliance activities.
• Experience with CAPA, complaint handling, change control, supplier quality, and document control systems.
• Strong ability to balance strategic leadership with hands-on execution.
• Ability to work full-time onsite at HQ in Eden Prairie, Minnesota.
• Open to candidates residing within a 45-minute drive.
• Must be authorized to work in the United States without sponsorship.

Nice To Haves

• Experience supporting Class II and/or Class III medical devices, preferred.

Responsibilities

• Lead the overall Quality Management System and ensure compliance with FDA Quality Management System Regulation (QMSR), ISO 13485, ISO 14971, and other applicable requirements.
• Build strong partnerships with executive leadership to align quality and regulatory strategies with business objectives.
• Direct and continuously improve core quality processes, including document control, record control, training, CAPA, change control, nonconformance management, customer feedback, and complaint handling.
• Ensure corrective and preventive actions are comprehensive, effective, and completed in a timely manner.
• Develop and implement quality objectives, metrics, and improvement initiatives aligned with company goals.
• Identify quality trends, analyze data, and drive corrective actions and continuous improvement projects.
• Maintain organizational inspection and audit readiness at all times.
• Partner closely with the contract manufacturer by driving quality requirements to the contract manufacturer.
• Lead internal audits, supplier audits, management reviews, and external regulatory or certification audits.
• Serve as management representative for quality-related compliance activities as appropriate.
• Act as the primary Quality leader for contract manufacturing oversight and supplier quality management.
• Lead supplier qualification, approval, monitoring, and requalification activities.
• Establish and maintain quality agreements with contract manufacturing and critical suppliers.
• Conduct and oversee supplier audits, quality investigations, CAPAs, and performance reviews.
• Partner with contract manufacturing organizations to resolve quality issues, implement improvements, and ensure ongoing compliance.
• Ensure product acceptance activities and supplier controls are effectively maintained within the outsourced manufacturing model.
• Lead regulatory strategy and submission activities for U.S. medical device compliance.
• Prepare and maintain FDA submissions and regulatory documentation, including product changes, reports, and other required filings.
• Assess regulatory impact of design, process, manufacturing, supplier, and labeling changes.
• Support product development projects by providing regulatory guidance and quality oversight.
• Serve as the primary interface with FDA and other applicable regulatory agencies.
• Monitor evolving regulations, standards, and guidance, and communicate business impacts to leadership.
• Support post-market regulatory compliance and reporting requirements.
• Lead, coach, develop, and evaluate Quality & Regulatory team members.
• Foster a culture of quality, accountability, compliance, and continuous improvement.
• Partner cross-functionally with operations, engineering, clinical, commercial, and executive leadership teams to achieve company objectives.
• Provide practical, business-oriented quality and regulatory guidance to support organizational growth and innovation.

Benefits

• eligible for annual discretionary bonus
• medical insurance including a High-Deductible Health Plan with an annual company HSA contribution of $2K for individual coverage or $4K for family coverage
• dental/vision insurance
• employer-paid life insurance plus STD & LTD coverage
• ample PTO/floating holidays/company paid holidays
• 401k with a 3% company match

What This Job Offers

• Job Type: Full-time
• Career Level: Director