Principal Regulatory Affairs Specialist (Medtech AI)

TL;DR

Principal Regulatory Affairs Specialist (Medtech AI): Developing and managing regulatory strategies for AI/ML-enabled Software as a Medical Device (SaMD) to achieve FDA clearance with an accent on strategic pathway assessment and clinical validation. Focus on leading FDA Pre-Submissions, drafting critical regulatory deliverables, and implementing AI/ML frameworks.

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

Salary: $160,000 – $200,000 + 15% performance bonus

Company

hirify.global is a remote-first medical device consultancy specializing in software engineering, AI/ML validation, cybersecurity, and FDA regulatory affairs.

What you will do

• Develop regulatory strategies including pathway assessments (510(k), De Novo, PMA) and predicate analysis.
• Design clinical validation approaches, including standalone performance testing and MRMC reader studies.
• Lead FDA Pre-Submission processes, drafting packages and translating feedback into actionable steps.
• Prepare and submit Breakthrough Device Designation (BDD) applications.
• Draft and own key regulatory deliverables such as Software Descriptions, Clinical Validation Plans, and PCCP documentation.
• Mentor junior regulatory staff and contribute to thought leadership in the AI/ML SaMD ecosystem.

Requirements

• 8+ years of experience in FDA regulatory affairs for medical devices, specifically with SaMD submissions.
• Proven track record of taking at least five SaMD through FDA clearance or approval.
• Deep familiarity with FDA's AI/ML guidance, PCCP framework, and standards (IEC 62304, ISO 14971, IEC 82304).
• Excellent regulatory writing skills tailored for FDA reviewers.
• Ability to lead client engagements independently and communicate complex strategies to executive audiences.
• Must be based in the United States (excluding Alaska and Hawaii).

Nice to have

• Experience taking at least one AI/ML device through FDA clearance or approval.
• Previous experience working at the FDA.
• Background in consulting roles.
• RAC certification or advanced degree in biomedical engineering or regulatory science.
• Experience implementing ISO 13485 and FDA-compliant QMS.

Culture & Benefits

• Fully remote work with flexible hours.
• Comprehensive PTO package and partial healthcare reimbursement.
• Automatic 3% contribution to a 401(k) retirement plan.
• Annual company retreat for team building and collaboration.
• Opportunity to shape the AI/ML regulatory practice and build a public reputation in the field.

Hiring process

• Application review and initial interviews.
• Short take-home exercise.
• Two reference checks.