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.
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