Regulatory Affairs Specialist Full Time NEW

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.

Accountabilities

• Develop and execute regulatory strategies for digital pathology products and AI-enabled healthcare solutions across North America and other regions, ensuring alignment with applicable regulatory frameworks.
• Prepare, compile, and submit regulatory filings and accreditation applications to agencies such as FDA, CMS-CLIA-LDT, CAP, SCC, and other global authorities, ensuring accuracy and timeliness.
• Maintain ongoing compliance through post-market surveillance activities, regulatory reporting, and monitoring of evolving requirements, including AI, privacy, and cybersecurity regulations.
• Lead engagement with regulatory bodies, notified entities, and competent authorities to support approvals, audits, inspections, and ongoing regulatory communications.
• Establish and maintain global regulatory databases, policies, and procedures, ensuring consistency and readiness across the product portfolio.
• Support quality systems integration by embedding regulatory requirements into change control, complaint handling, training, document management, and internal audits.

Requirements

• Bachelor’s degree in Computer Science, Life Sciences, or a related field.
• Minimum of 3 years of regulatory affairs experience within a regulated life sciences or healthcare environment in the United States.
• Strong knowledge of medical device and Software as a Medical Device (SaMD) regulations.
• Experience with histopathology laboratory accreditation standards such as CAP, CLIA, and ISO 15189:2022.
• Familiarity with digital pathology systems and imaging technologies is highly advantageous.
• Exposure to AI technologies, emerging regulatory frameworks, and data privacy/security standards is a plus.
• Understanding of healthcare compliance topics such as billing practices and regulatory risk frameworks is an advantage.
• Strong analytical, communication, and stakeholder management skills with the ability to work in cross-functional global teams.

Benefits

• Competitive salary with performance-based annual increments.
• Remote-first working model based in the United States.
• Opportunity to work on innovative, high-impact healthcare and AI-driven diagnostic technologies.
• Exposure to global projects and collaboration with international teams across Europe, North America, and Canada.
• Strong career development opportunities in a fast-growing, mission-driven environment.
• Continuous learning, training programs, and professional development support.
• Inclusive, multicultural, and highly collaborative team culture.
• Meaningful work contributing directly to improved patient outcomes and faster, more accurate diagnoses.

How Jobgether Works

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role’s core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?

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