Senior AI/ML Regulatory Consultant (MedTech)

TL;DR

Senior AI/ML Regulatory Consultant (MedTech): Leading regulatory engagements for AI/ML-enabled Software as a Medical Device (SaMD) with an accent on FDA submission strategies, clinical validation planning, and breakthrough device designations. Focus on driving complex 510(k) and De Novo clearances while advising clients on evolving FDA AI/ML frameworks.

Location: Must be based in the U.S. (Remote)

Salary: $140,000 – $180,000 (plus 15–20% performance-based bonus)

Company

hirify.global is a remote-first professional services firm specializing in medical device software development, FDA regulatory consulting, and cybersecurity.

What you will do

• Lead sprint-based Fast 510(k) engagements from kickoff to submission within three months.
• Develop comprehensive regulatory strategies including pathway assessments, intended use scoping, and clinical study design.
• Prepare and manage Breakthrough Device Designation (BDD) applications and FDA Pre-Submissions.
• Draft essential regulatory documentation such as Software Descriptions, Clinical Validation Plans, and PCCP documentation.
• Advise clients on FDA AI/ML guidance, including Good Machine Learning Practice (GMLP).
• Mentor junior regulatory staff and contribute to company thought leadership.

Requirements

• 5+ years of experience in FDA regulatory affairs for medical devices.
• Must have direct experience leading at least one AI/ML device through FDA clearance (510(k), De Novo, or PMA).
• Strong familiarity with FDA AI/ML guidance, PCCP framework, IEC 62304, and ISO 14971.
• Expertise in clinical validation design for AI/ML devices.
• Excellent regulatory writing skills for precise communication with FDA reviewers.
• Must be authorized to work in the U.S. and currently located in the U.S.

Nice to have

• Experience with Breakthrough Device Designation applications.
• Former FDA experience.
• Hands-on experience with ISO 13485 and FDA-compliant Quality Management Systems.
• RAC certification or advanced degree in biomedical engineering or regulatory science.
• Familiarity with software development practices and ML pipelines.

Culture & Benefits

• Competitive base salary with performance-based bonuses.
• Fully remote work model with flexible hours.
• Partial healthcare reimbursement.
• 401(k) retirement plan with 3% automatic company contribution.
• Annual company retreat for team building and collaboration.
• Opportunity to influence the AI/ML regulatory practice at a high-impact firm.