Quality & Regulatory Director - 2596-20

An innovative, publicly traded medical device company transforming the treatment of fluid overload with its Aquadex SmartFlow System, an FDA-cleared technology that is changing how critically ill heart failure, critical care, and pediatric patients are treated. Following a significant Medicare reimbursement increase and continued investment in new technologies and indications, the company is entering an exciting phase of growth and product expansion. As the Quality & Regulatory Director, you'll have the unique opportunity to lead the company's Quality & Regulatory function while helping shape the future of its product portfolio. This highly visible role offers broad ownership across Quality Systems, FDA compliance, supplier quality, contract manufacturing, design assurance, and new product development. Working closely with executive leadership, you'll influence quality strategy, support innovative product initiatives, and play a key role in ensuring the organization continues to deliver safe, high-quality technologies that improve patient outcomes. If you're looking for an opportunity where your ideas, leadership, and technical expertise will have a direct impact on a growing medical device company, this is a chance to truly make your mark.

• Own the Quality & Regulatory function: Take on a highly visible leadership role with broad ownership across Quality Systems, Regulatory, Design Assurance, supplier quality, and contract manufacturing, where your decisions directly influence the company's success.
• Help shape the future of innovative medical technology: Support the continued growth of the FDA-cleared Aquadex SmartFlow System while contributing to exciting pipeline programs, including pediatric indication expansion and next-generation technologies.
• Make a measurable impact: This isn't a role where you'll inherit a large team and simply maintain the status quo. You'll work alongside executive leadership to optimize and evolve the QMS while helping position the organization for future growth.
• Lead with autonomy: Enjoy the opportunity to drive strategy, influence key decisions, and partner cross-functionally with Engineering, Operations, Clinical, and Executive Leadership in a collaborative, entrepreneurial environment.
• Balance strategy with hands-on leadership: If you enjoy building processes, solving complex quality challenges, supporting new product development, and remaining technically engaged, this role offers the best of both worlds.
• Join a company entering an exciting growth phase: With expanded reimbursement supporting broader adoption of ultrafiltration therapy, continued investment in product innovation, and a growing commercial footprint, you'll have the opportunity to make a lasting impact at a pivotal time in the company's evolution.
• 8 years of Quality department exper in medical device.
• Open to managers who want to move into director-level positions as long as they meet the qualifications.
• Bachelor's degree (technical degree preferred, but not required)
• Comfortability with ISO 1345 and 14971
• Self-starter, works well independently, comfortable working alone/autonomous, strategic mindset/thinker
• Resides in MN/near HQ. Not open to relo at this time
• Comfortable with a start-up feel environment, autonomous, self-starter, works well independently, and has a strategic mindset/thinker