Senior Quality Regulatory Consultant

To support a growing practice, the full-time Senior Quality Regulatory Consultant will lead client engagements focused on quality management systems and regulatory strategies, working remotely to define project-level strategies and ensure compliance with applicable standards. Key responsibilities Lead assessment and enablement engagements, advising clients on quality management systems and regulatory strategies Define project-level quality and regulatory strategy in collaboration with delivery teams, ensuring project success Own quality agreements and serve as the final reviewer for quality plans and medical device files before transfer Required qualifications BS or MS in a relevant technical, quality, or regulatory field, or equivalent experience 6+ years of experience in medical device or SaMD quality/regulatory consulting or leadership Deep knowledge of ISO 13485, IEC 62304, ISO 14971, and related standards within US FDA and EU MDR frameworks Experience scoping and defining quality and regulatory strategies at a strategic level across multiple engagements Strong communication skills, with experience negotiating quality agreements and advising client executives