Our start-up client is developing breakthrough medical technologies and and they’re adding a Senior Regulatory Affairs Specialist to help bring these innovations to patients worldwide.

In this role, you’ll own key regulatory activities that drive U.S. and global submissions, ensure compliance, and keep products aligned with evolving FDA and EU MDR requirements. You’ll collaborate closely with engineering and clinical teams, shaping strategy and ensuring documentation is accurate, complete, and compliant.

You're role with the company:

• Prepare and support U.S. (IDE, PMA, 510(k)) and international (EU MDR, Health Canada, Japan) submissions.

• Review and finalize engineering test reports, labeling, and marketing materials for compliance.

• Partner cross-functionally to resolve regulatory issues and respond to agency inquiries.

• Monitor global regulatory changes and communicate updates across teams.

• Assess product/manufacturing changes for regulatory impact and documentation needs.

Desired Profile:

• Bachelor’s degree in Engineering or a related field.

• 3+ years of medical device Regulatory Affairs experience.

• Proven success writing, reviewing, and editing regulatory and technical documentation.

• Experience with FDA and EU MDR submissions (IDE, PMA).

• Detail-oriented, organized, and able to manage multiple projects in a fast-paced environment.

• Up to 10% travel.

Join a nimble, mission-driven team where your work directly impacts patient care — and where your regulatory expertise truly matters.