Associate QA/RA Consultant & Project Manager (MedTech)

TL;DR

Associate QA/RA Consultant & Project Manager (MedTech): Supporting FDA submissions for Software as a Medical Device (SaMD) and implementing Quality Management Systems with an accent on regulatory strategy, technical writing, and project coordination. Focus on developing regulatory roadmaps, drafting submission packages, and guiding clients through AI/ML frameworks and clinical validation.

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

Company

A remote-only professional services firm specializing in medical device software development, FDA regulatory consulting, and cybersecurity.

What you will do

• Develop regulatory strategies and conduct pathway assessments (510(k), De Novo, PMA), including intended use scoping and clinical study design.
• Prepare and submit Breakthrough Device Designation (BDD) applications and Pre-Submission request packages.
• Draft high-quality FDA regulatory documentation, such as Software Descriptions, Clinical Validation Plans, and Algorithm Change Protocols.
• Advise clients on FDA's AI/ML framework, including Good Machine Learning Practice (GMLP) and predetermined change control plans (PCCP).
• Manage project timelines, task boards, and client relationships using Notion to ensure alignment and delivery.
• Guide the implementation and maintenance of ISO 13485 and FDA-compliant Quality Management Systems (QMS).

Requirements

• Degree in biomedical engineering or a related field.
• FDA submission knowledge required.
• Must be based in the United States.
• Strong organizational skills and exceptional attention to detail.
• Overall GPA of 3.5 or higher is typically expected.

Nice to have

• Hands-on experience implementing ISO 13485 and FDA-compliant QMS.
• Demonstrated experience with pre-sub, breakthrough, or full FDA submissions.

Culture & Benefits

• Mentorship and detailed feedback from experienced regulatory and software professionals.
• Fully remote work with flexible hours.
• 10% performance-based bonus.
• Partial healthcare reimbursement and automatic 3% contribution to a 401(k) retirement plan.
• Annual company retreat for team building and collaboration.