Job Title

Senior Manager - Regulatory Affairs & Quality AssuranceWant to apply Read all the information about this position below, then hit the apply button.Hartmann Young is partnered with an innovative and established diagnostics company, seeking a Senior Manager of Regulatory Affairs & Quality Assurance to lead and execute regulatory strategy and quality systems compliance. This is a high-impact, hands-on leadership role suited to someone who thrives in a position with roll-up-your-sleeves operational responsibilities. We're looking for someone collaborative, who has proven experience navigating both FDA and IVDR regulatory environments in the in vitro diagnostics (IVD) space.Key responsibilities Lead, maintain, and continuously improve the companys Quality Management System (QMS) in compliance with both IVDR, and eventually FDA standards.Drive regulatory strategy for current and future IVD products, ensuring successful product registrations and post-market compliance.Serve as primary contact for regulatory bodies, notified bodies, and auditors.Prepare and submit regulatory dossiers (510(k), Technical Files, etc.).Collaborate closely with R&D, Operations, and Clinical teams to ensure regulatory and quality requirements are embedded across product development and lifecycle.Provide hands-on support for document control, design history files, validation protocols, and day-to-day RA/QA activities.Required Experience Minimum 57 years in Regulatory and Quality roles in the IVD, medical device, or molecular diagnostics industry.Solid understanding and working experience with IVDR and EU regulatory frameworks.Proven experience with FDA regulatory submissions (e.g., 510(k)) and compliance audits.Hands-on mindset; someone who enjoys doing the work as much as guiding or managing a team. Youll join a mission-driven team developing diagnostic solutions that make a real-world impact. Youll have the chance to shape quality and regulatory operations in a meaningful, collaborative way.If this sounds like you, reach out on ellen.stanton@hartmannyoung.com or apply directly below. We'd love to hear from you!