Director of Regulatory Affairs and Quality Assurance

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.

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 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.