About the role
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<p data-start="0" data-end="198"><strong>This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Regulatory Affairs Specialist based in United States.</strong></p>
<p data-start="200" data-end="1252">This role plays a critical part in ensuring medical device products meet global regulatory and quality standards across their full lifecycle, from development through commercialization and post-market activities. You will support cross-functional teams in translating complex regulatory requirements into actionable guidance that enables compliant product design, validation, labeling, and market release. The position sits at the intersection of regulatory affairs, quality systems, and product development, requiring strong collaboration with engineering, clinical, manufacturing, and commercial teams. You will contribute to regulatory submissions across multiple regions while helping ensure ongoing compliance with FDA, ISO, and international standards. This is a highly detail-oriented and impactful role where your work directly supports safe, effective diagnostic solutions reaching global markets. The environment is collaborative, fast-paced, and innovation-driven, with strong emphasis on accuracy, documentation, and continuous improvement.</p>
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