Job description

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Regulatory Affairs Specialist in United States.

This role sits at the intersection of regulatory strategy, digital health innovation, and global compliance within a fast-evolving life sciences environment. The position focuses on ensuring that digital pathology products and AI-enabled solutions meet stringent regulatory and accreditation requirements across North America and international markets. You will collaborate closely with cross-functional teams including QA/RA, R&D, laboratory operations, legal, and commercial stakeholders to shape regulatory pathways and ensure successful product approvals. The role also involves direct engagement with regulatory authorities and notified bodies across the U.S., Canada, and Europe. Operating in a highly collaborative global organization, you will contribute to both strategic planning and hands-on regulatory execution. This is a high-impact position where your work directly supports product innovation and improved patient outcomes in healthcare.