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. * * * **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. If you are looking for an environment where you can make a significant contribution, take ownership of meaningful wo…