Application Guide

How to Apply for FDA Regulatory Attorney – Class III IVD / Companion Diagnostics

at Axiomtalentplatform

🏢 About Axiomtalentplatform

Axiomtalentplatform operates as a specialized legal talent platform connecting experienced attorneys with companies on a flexible basis, offering remote opportunities for seasoned professionals. Their model allows attorneys to work on high-impact regulatory projects without traditional firm constraints, making it ideal for those seeking autonomy while tackling complex FDA submissions.

About This Role

This role involves leading FDA regulatory strategy and submissions for high-risk Class III IVDs and companion diagnostics, serving as the primary FDA interface for PMA lifecycle management. You'll directly own Modular PMAs, Q-Subs, and post-approval changes, making critical decisions that impact product approval and market access in a specialized remote environment.

💡 A Day in the Life

A typical day involves reviewing PMA submission documents, preparing for FDA meetings or Q-Subs, and advising on regulatory strategy for ongoing IVD projects. You might draft responses to FDA requests, coordinate with cross-functional teams on submission timelines, and manage post-approval change documentation, all while working remotely with periodic client check-ins.

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Interview Prep

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🎯 Who Axiomtalentplatform Is Looking For

  • A licensed attorney with 5+ years of in-house experience specifically at medical device or diagnostics companies, not just law firms
  • Has personally owned and executed Class III PMA IVD submissions from strategy through FDA negotiation, not just assisted on them
  • Possesses recent, hands-on experience with Modular PMA structure, PCCPs, SIRs, and Q-Sub meetings within the past 2-3 years
  • Can demonstrate specific examples of leading FDA meetings and negotiating positions on complex IVD regulatory issues

📝 Tips for Applying to Axiomtalentplatform

1

Quantify your PMA experience: specify exactly how many Class III IVD submissions you've led (e.g., 'led 3 full PMAs and 5 Modular PMAs for oncology companion diagnostics')

2

Highlight remote work proficiency: emphasize experience with distributed teams and self-directed regulatory project management

3

Mention specific FDA divisions you've worked with (e.g., CDRH, OIVD) and recent regulatory guidance you've implemented

4

Tailor your resume to show progression from drafting to strategic ownership of submissions, not just participation

5

Research Axiom's platform model and address how you'd thrive in their flexible, project-focused environment

✉️ What to Emphasize in Your Cover Letter

['Demonstrate deep understanding of Class III IVD regulatory pathways and recent FDA trends in companion diagnostics', "Provide concrete examples of successful FDA negotiations or challenging submission scenarios you've resolved", "Explain why Axiom's flexible platform model appeals to you as an experienced regulatory attorney", "Connect your specific PMA lifecycle experience to their requirement for 'ownership' of strategy and execution"]

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🔍 Research Before Applying

To stand out, make sure you've researched:

  • → Investigate Axiom's specific client base in medical devices/IVDs to understand their project types
  • → Review recent FDA guidance documents for Class III IVDs and companion diagnostics (2023-2024)
  • → Look into Axiom's platform structure and how attorneys typically engage with clients remotely
  • → Research current FDA/CDRH priorities and enforcement trends for IVD products

💬 Prepare for These Interview Topics

Based on this role, you may be asked about:

1 Walk me through your most complex Modular PMA submission and how you structured it for FDA review
2 Describe a time you had to negotiate a difficult position with FDA/CDRH on a companion diagnostic issue
3 How do you manage post-approval changes and PMA supplements while maintaining compliance?
4 What's your approach to preparing for and leading Q-Sub meetings with FDA?
5 How have you handled a situation where FDA requested significant additional information on a PMA submission?
Practice Interview Questions →

⚠️ Common Mistakes to Avoid

  • Claiming general regulatory experience without specific Class III IVD/companion diagnostic examples
  • Focusing only on law firm experience without demonstrating in-house medical device company background
  • Being vague about submission ownership (using 'assisted with' or 'contributed to' instead of 'led' or 'owned')

📅 Application Timeline

This position is open until filled. However, we recommend applying as soon as possible as roles at mission-driven organizations tend to fill quickly.

Typical hiring timeline:

1

Application Review

1-2 weeks

2

Initial Screening

Phone call or written assessment

3

Interviews

1-2 rounds, usually virtual

✓

Offer

Congratulations!

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Good luck with your application to Axiomtalentplatform!

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