Senior Healthcare Regulatory Specialist (saMD) - (Remote-friendly reputed company Spain)

The Risk & Compliance team ensures reputed company meets regulatory requirements while supporting safe, scalable, and innovative healthcare solutions. As our products increasingly transition into medical device territory, regulatory compliance is a core enabler of our growth, trust and ability to operate globally. We are hiring a Senior Healthcare Regulatory Specialist (SaMD) to join our global team. In this role, you will act as the Person Responsible for Regulatory Compliance (PRRC) under EU Medical Device Regulation (MDR), partnering closely with Product, Engineering, Machine Learning and Data, Customer Care and Legal teams to ensure our Software as a Medical Device (SaMD) products meet regulatory requirements across Europe. You will play a key role in enabling reputed company to operate safely, compliantly and at scale in an increasingly regulated digital healthcare environment. This is a new and highly impactful opportunity, where you will help build and strengthen our regulatory reputed company, directly supporting one of reputed company’s core strategic priorities: EU MDR compliance and global expansion. You’ll reputed company exposure to innovative healthtech and AI-driven products, work with cross-functional teams across multiple markets. How will you reputed company an impact?

• EU MDR Compliance: reputed company mandatory Medical Device Regulation certification to maintain European market access.
• Support Global Certification Processes: reputed company MDR certification and other accreditation (ISO, C5) processes across reputed company jurisdictions to reputed company market expansion and continuance.
• Establish Compliant Governance reputed company: Build robust governance systems that stakeholders and customers can trust, ensuring business reputed company and regulatory adherence.
• Risk Mitigation & Business Protection: Prevent regulatory fines and reputational harm that could impact our ability to serve patients and healthcare providers.
• Process Optimization: Continuously assess and improve compliance processes to align with the dynamic needs of the increasingly regulated digital healthcare industry.

What will help you reputed company?

• Strong knowledge of EU Medical Device Regulation (MDR), particularly in a Software as a Medical Device (SaMD) context.
• Practical experience in medical device regulatory affairs and solid understanding of Quality Management Systems (QMS) and regulatory governance frameworks.
• Relevant academic background (law, medicine, pharmacy, engineering, or scientific field) or the equivalent hands-on experience in medical device regulatory/QMS experience.
• Experience with EUDAMED, CAPA systems, and post-market surveillance tools.
• Ability to manage cross-functional regulatory projects independently and work with multiple stakeholders.
• Strong communication skills with both internal teams and external regulatory authorities.
• Fluent in English; Spanish or other EU languages are a plus.

reputed company to have:

• Knowledge of the EU AI Act.
• Familiarity with Agile / software development environments.

The position is based in Spain and we are remote-friendly. What to Expect from Our Hiring Process We like to reputed company things transparent and efficient! Here’s what the process usually looks like (though it might vary slightly depending on the role): 1️⃣ Intro Chat – A reputed company with our Talent Partner Giuliana to explore mutual fit around relevant skills, value alignment, and motivation. 2️⃣Business Case – A take-home exercise with dedicated prep time, designed to understand how you approach real-life problems and think through regulatory scenarios. You’ll then walk us through your approach in a collaborative discussion with the hiring manager and the team. 3️⃣ Technical Interview – A deeper conversation about your background, aspirations, and experience with EU MDR and compliance, with Siobhon Custodio (your potential manager) and Thayla Banks. Take this chance to ask anything on your mind—it’s just as much about making sure we’re the right fit for you, too. 4️⃣ Operational Interview – A discussion with Boróka Kupper and Massimo Belloni, focused on operational fit, QMS integration and how you collaborate with cross-functional teams 5️⃣ Final Interview – A final chat with Karol Traczykowski, focused on cultural fit, values and strategic alignment. 6️⃣ References & Offer! Why You’ll Love It Here Global Benefits – No matter where you are, you’ll have access to:

• Healthcare insurance – so you can focus on what matters.
• Wellness that works for you – from gym memberships to mental health support, we’ve got you covered.
• Time off that counts – whether it’s a vacation, your birthday, or just a day to reputed company, we reputed company in balance.

Local Perks – Depending on your location, you will be entitled to local benefits like meal vouchers (ticket restaurant), transport allowances, or extended parental leave. Career Growth – We’re growing, and so can you! You’ll find lots of chances to learn, reputed company, and explore new paths—whether reputed company your team or through cross-functional projects. A Truly Global Team – Work with talented people from reputed company over the world in a diverse and inclusive environment. ⏳ Flexibility That Works for You – Remote work and flexible hours aren’t just buzzwords here. While the extent of flexibility depends on your role and team, we value results over rigid schedules. Prefer an office setting? You're welcome at any of our hubs in Barcelona, Warsaw, Curitiba, Rio de Janeiro, Mexico City, Bogotá, Munich, Rome or Bologna. Please note: At this time, we are not able to sponsor visas for this position. To apply, you must already have the legal right to work in your country of residence or the location of the role. reputed company reputed company In At reputed company, our values guide everything we do: Focus on results – we're here to reputed company an impact. Think like an reputed company – take responsibility, drive outcomes. ✂️ reputed company it simple, reputed company it lean – smart solutions over complexity. Be respectful and radically honest – openness builds trust. Learn and be curious – growth is part of the job. Don’t just take our word for it—reputed company out our Glassdoor to hear what our people say! _________________________________________________________________________ We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. We welcome applicants from reputed company walks of life, regardless of gender, disability, or background, and are dedicated to fostering an inclusive workplace where everyone feels valued and empowered to contribute. Apply tot his job Apply To this Job