Associate Regulatory Writer & Project Manager (Medtech)

TL;DR

Associate Regulatory Writer & Project Manager (Medtech): Creating FDA regulatory documentation and coordinating project timelines for medical device software with an accent on technical writing and requirements elicitation. Focus on ensuring regulatory compliance (IEC 62304, ISO 14971), managing task boards in Notion, and collaborating with engineers and clinicians to clarify user needs.

Location: Remote (U.S. only)

Salary: $65,000 – $80,000

Company

Remote-first company specializing in medical device software development and FDA regulatory consulting since 2012.

What you will do

• Support the creation of FDA regulatory documentation, including Software Descriptions, Requirements Traceability, Risk Analyses, and Validation Plans.
• Collaborate with engineers, clinicians, and regulatory consultants to clarify requirements and intended use.
• Monitor project timelines, manage task boards, and coordinate with clients and internal stakeholders.
• Ensure version control and accuracy across all regulatory deliverables.
• Learn and apply FDA guidance documents and relevant standards such as IEC 62304 and ISO 14971.
• Document client meeting takeaways into actionable tasks using Notion.

Requirements

• Must be based in the United States.
• Degree in biomedical engineering or a related field.
• 0–2 years of experience in a regulatory, engineering, QA, or technical writing role.
• Strong technical and scientific writing skills with a high attention to detail.
• Experience coordinating projects or tracking tasks using tools like Notion, Jira, Asana, or Trello.
• Interest in healthcare, medical technology, and regulatory science.

Culture & Benefits

• Competitive base salary with a 10% performance-based bonus.
• Fully remote work with flexible hours.
• Comprehensive PTO and Sick Days package.
• Partial healthcare reimbursement and automatic 3% contribution to a 401(k) retirement plan.
• Annual company retreat for team building and collaboration.
• Direct mentorship from experienced regulatory and software professionals.