Senior Regulatory Affairs Specialist

What you'll do

• Set regulatory pathways with product teams, review claims and AI-generated outputs, and prepare launch reviews.
• Prepare and coordinate sections of 510(k), De Novo, and Pre-Submission packages; support design controls, evidence planning, and international submissions.
• Maintain regulatory records and quality-system support, assess product changes, and translate regulatory intelligence into practical guidance.

What they ask for

• 5+ years of regulatory affairs experience with medical devices, software as a medical device (SaMD), or diagnostics.
• Bachelor's degree in engineering, life sciences, or a related technical field.
• Hands-on experience with 510(k), De Novo, or Pre-Submission work, including preparing submission content.
• Working knowledge of FDA device regulations and guidance, ISO 13485, ISO 14971, IEC 62304, and quality management system requirements under 21 CFR Part 820 (QMSR).

Nice to have

• AI/ML-enabled device experience, including predetermined change control plans and performance evaluation.
• Experience with laboratory-developed tests, CLIA, in vitro diagnostics, imaging devices, cybersecurity, post-market obligations, IRB submissions, MDSAP audits, or RAC certification.

Tools

510(k), De Novo, Pre-Submission, ISO 13485, ISO 14971, IEC 62304, EU MDR, 21 CFR Part 820 (QMSR)

AI focus

Regulatory oversight of AI-enabled products, including reviewing AI-generated outputs and monitoring policy for AI-enabled devices; use AI tools to accelerate regulatory work while verifying and correcting their outputs.