Director Of Regulatory Affairs

1 week ago

Cambridge, United States Bridgeway Professionals Full time

Director of Regulatory Affairs and 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:

  1. Own the regulatory function, including managing a small regulatory team.
  2. Lead efforts to obtain FDA 510(k) clearance, working closely with internal teams and external partners.
  3. Design and execute clinical validation studies.
  4. Build and implement quality assurance systems from the ground up.
  5. Ensure compliance with US and global regulatory standards, including European regulations.
  6. Collaborate with internal stakeholders and external clinicians at major US medical facilities.
  7. Work in a flexible, hands-on environment where you will create and implement new processes.

What You’ll Need:

  1. Proven experience with FDA 510(k) submissions and medical device regulatory requirements.
  2. Strong background in both hardware and software regulatory affairs and quality assurance.
  3. Experience designing and executing clinical validation studies.
  4. Ability to build scalable regulatory and quality systems from scratch.
  5. Experience leading and mentoring a regulatory team.
  6. Practical, hands-on approach and a startup mentality—comfortable working in an evolving environment.
  7. Strong collaboration skills and the ability to work closely with cross-functional teams, customers, and clinicians.
  8. 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:

  1. Be a key leader in driving regulatory and quality systems for an innovative medical device company.
  2. Hands-on role with significant impact on long-term growth and compliance.
  3. Competitive compensation up to $240K plus stock options.
  4. Collaborate with diverse teams across the US and internationally.
  5. Flexible, startup-like environment where you can make a real difference.
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