Director of Regulatory Affairs & Quality Assurance (RA/QA)

We're working closely with the C-suite at an exciting medical-device company to recruit a Director of Regulatory Affairs & Quality Assurance, who will lead the development and execution of comprehensive regulatory and quality systems. This role is pivotal in both securing immediate FDA 510(k) approval for next-generation products and laying the groundwork for scalable operations that will support future growth.

What You'll Do:

- Own the regulatory function, including managing a small regulatory team.

- Lead efforts to obtain FDA 510(k) clearance, working closely with internal teams and external partners.

- Design and execute clinical validation studies.

- Build and implement quality assurance systems from the ground up.

- Ensure compliance with US and global regulatory standards, including European regulations.

- Collaborate with internal stakeholders and external clinicians at major US medical facilities.

- Work in a flexible, hands-on environment where you will create and implement new processes.

 

Qualifications

What You’ll Need:

- Proven experience with FDA 510(k) submissions and medical device regulatory requirements.

- Strong background in both hardware and software regulatory affairs and quality assurance.

- Experience designing and executing clinical validation studies.

- Ability to build scalable regulatory and quality systems from scratch.

- Experience leading and mentoring a regulatory team.

- Practical, hands-on approach and a startup mentality—comfortable working in an evolving environment.

- Strong collaboration skills and the ability to work closely with cross-functional teams, customers, and clinicians.

- Must be based in the Boston area or within a 2-3 hour drive, with the ability to come to the office regularly.

Why is This a Great Opportunity

Why You’ll Want to Join:

- Be a key leader in driving regulatory and quality systems for an innovative medical device company.

- Hands-on role with significant impact on long-term growth and compliance.

- Competitive compensation up to $240K plus stock options.

- Collaborate with diverse teams across the US and internationally.

- Flexible, startup-like environment where you can make a real difference.