Senior Regulatory Affairs Specialist (Medtech)

TL;DR

Senior Regulatory Affairs Specialist (Medtech): Leading regulatory pathways for AI/ML-enabled Software as a Medical Device (SaMD) with an accent on FDA submissions and strategy. Focus on driving 510(k) and De Novo clearances, designing clinical validation approaches, and navigating the evolving FDA AI/ML framework.

Location: Remote (U.S. only, excluding Alaska and Hawaii)

Salary: $120,000 – $160,000

Company

A remote-first medical device consultancy specializing in software engineering, AI/ML validation, cybersecurity, and regulatory affairs.

What you will do

• Lead Fast 510(k) engagements to drive AI/ML SaMD submissions from kickoff to FDA submission within 3 months.
• Develop regulatory strategies, including pathway assessments (510(k), De Novo, PMA), intended use scoping, and clinical study design.
• Prepare and submit Breakthrough Device Designation (BDD) applications.
• Manage FDA Pre-Submission packages and lead interactions with the FDA.
• Design clinical validation approaches, such as standalone performance testing and MRMC reader studies.
• Draft key regulatory deliverables, including Software Descriptions, Clinical Validation Plans, and Algorithm Change Protocols.

Requirements

• 5+ years of experience in FDA regulatory affairs for medical devices, specifically with AI/ML SaMD submissions.
• Proven experience taking at least one AI/ML device through FDA clearance or approval.
• Deep familiarity with FDA's AI/ML guidance, PCCP framework, and standards such as IEC 62304 and ISO 14971.
• Must be based in the U.S. (excluding Alaska and Hawaii).
• Excellent regulatory writing skills and ability to communicate strategy to technical and executive audiences.

Nice to have

• RAC certification or an advanced degree in biomedical engineering or regulatory science.
• Former experience working at the FDA.
• Hands-on experience implementing ISO 13485 and FDA-compliant Quality Management Systems.
• Familiarity with software development practices and ML pipelines.

Culture & Benefits

• Competitive base salary with a 12% performance-based bonus.
• Fully remote work with flexible hours and a comprehensive PTO package.
• Partial healthcare reimbursement and automatic 3% contribution to a 401(k) plan.
• Annual company retreat for team building and collaboration.
• Opportunity to shape the company's AI/ML regulatory practice.

Hiring process

• Application review and initial contact.
• Interviews and a short take-home exercise.
• Two reference checks.