Senior Manager of Regulatory and Quality - Diagnostics

Senior Manager – Regulatory Affairs & Quality AssuranceHartmann 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 bothFDAandIVDRregulatory environments in the in vitro diagnostics (IVD) space.Key responsibilitiesLead, maintain, and continuously improve the company’sQuality Management System (QMS)in compliance with both IVDR, and eventually FDA standards. Driveregulatory strategyfor current and future IVD products, ensuring successfulproduct registrationsandpost-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. Providehands-on supportfor document control, design history files, validation protocols, and day-to-day RA/QA activities.Required ExperienceMinimum 5–7 yearsin Regulatory and Quality roles in the IVD, medical device, or molecular diagnostics industry. Solid understanding and working experience withIVDRand EU regulatory frameworks. Proven experience withFDA 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.You’ll join a mission-driven team developing diagnostic solutions that make a real-world impact. You’ll 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!