Senior Regulatory Affairs Officer

Job description

About Vitestro

Vitestro is pioneering the future of blood collection with the Aletta® Autonomous Robotic Phlebotomy Device™ (ARPD™), a medical device that 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, the company is scaling its impact as it places its first devices with customers and expands internationally.

Vitestro is looking for a hands-on Senior Regulatory Affairs Specialist to support its global regulatory strategy and execution as it scales its 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.

What you bring

• MSc or PhD in engineering, healthcare or life sciences
• 7+ years of Regulatory Affairs experience in the medical device industry, with demonstrated end-to-end responsibility for regulatory deliverables
• Excellent verbal and written communication, supporting strong organizational skills
• Experience with U.S. FDA (pre-)submissions with demonstrated success in obtaining 510(k) clearance
• Experience with preparing CE Marking submissions and significant changes under the MDR, working knowledge of relevant standards and regulations
• Experience with complex, active medical devices
• Full-time availability, onsite presence in Utrecht at least 3 days per week

Nice to have

• FDA De Novo and/or PMA experience
• Experience leading Notified Body and/or FDA audits
• Health Canada and/or UKCA/MHRA submission experience

How we work

At Vitestro, ownership is not a slogan - it is an expectation. We trust people to take responsibility, make decisions, and drive work forward.

We believe breakthroughs happen when talented people combine dedication, accountability, and teamwork. That means:

• We take initiative rather than wait for direction.
• We focus on execution and delivering results.
• We proactively remove blockers and help each other succeed.
• We challenge ideas, not people.
• We continuously learn, improve, and raise the bar.
• We celebrate team success over individual heroics.
• We move fast, but we do so thoughtfully.
• We care deeply about quality because the technology we build ultimately impacts patients and healthcare professionals.

What we offer

• Competitive salary including pension plan.
• 25 days of annual leave based on a full-time position.
• Hybrid work model.
• Working together in a highly skilled team with our home base in Utrecht.
• Frequent out-of-work activities and an annual company weekend away.
• Annual training budget of €2,000.
• Opportunity to help shape a new global industry niche: autonomous medical robotics.

We offer an environment where you can make a lot of impact, as you are joining a growing MedTech scale-up. Our team enjoys solving the challenges involved in developing, manufacturing, and commercializing our breakthrough medical device. In our open culture, we strive for excellence, challenge each other, and learn and teach regardless of age, nationality, or gender.