Senior Regulatory Affairs Officer

About Vitestro

Founded in 2017 in Utrecht, Vitestro is pioneering the future of blood collection with the Aletta® Autonomous Robotic Phlebotomy Device™ (ARPD™). This groundbreaking medical device combines advanced multi-modal imaging, robotics, and AI to perform the diagnostic blood draw procedure autonomously.

By addressing critical healthcare staffing shortages and improving patient experience, Vitestro is transforming one of the most common and essential medical procedures. With more than 90 team members and growing rapidly, we are scaling our impact as we place our first devices with customers and expand internationally.

At Vitestro, we are committed to continuous innovation and improvement. Join us as our new

Senior Regulatory Affairs Specialist

We are looking for a hands-on Senior Regulatory Affairs Specialist to support Vitestro’s global regulatory strategy and execution as we scale our autonomous robotic medical device across multiple markets.

In your first months, you’ll focus on

• Support regulatory submissions and strategy for the U.S. and EU, preparing for market launch and commercialization
• Manage significant change assessments and regulatory impact assessments across product, software, manufacturing, labeling, and supplier changes.
• Interact with Notified Bodies and regulatory authorities, including submission responses, audit support, and follow-up actions.
• Partner with R&D, Quality, Clinical, Operations, and Product teams to embed regulatory requirements into product development and lifecycle processes.
• Monitor regulatory developments and translate them into practical guidance for the organization.

This is what your success looks like

After 12 months, you have strengthened Vitestro’s regulatory readiness and lifecycle processes using pragmatic judgment and strong communication skills. You have supported effective Notified Body and authority interactions, contributed to submissions, ensuring robust technical documentation and change assessments, and helped prepare Vitestro for broader commercial scaling and future international expansion. You have become a trusted regulatory partner for R&D, Quality, Clinical, Operations, and Commercial teams, helping the company move faster while maintaining regulatory rigor.