Senior Healthcare Regulatory Specialist (saMD) - (Remote-friendly within Sp at Docplanner

Barcelona, Catalonia, Spain -

Full Time

Start Date

Immediate

Expiry Date

29 Apr, 26

Salary

0.0

Posted On

29 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

EU Medical Device Regulation, Software as a Medical Device, Regulatory Affairs, Quality Management Systems, EUDAMED, CAPA Systems, Post-Market Surveillance, Cross-Functional Project Management, Communication Skills, Fluent English, Spanish, Agile Environments

Industry

technology;Information and Internet

Description

Company Description At Docplanner Group, we’re on a mission to help people live longer, healthier lives. As the world’s largest healthcare platform, each month, we connect 24 million patients with 280k doctors across 13 countries (through brands like ZnanyLekarz, Doctoralia, MioDottore, DoktorTakvimi, and jameda). Our marketplaces, SaaS and AI tools simplify daily tasks and help doctors, clinics and hospitals work more efficiently, so they can focus on what really matters: caring for their patients. Learn more about our products here: pro.doctoralia.es Why join us? 📊 Real impact – We help doctors help patients. Your work truly makes a difference. 📈 At scale, yet agile – 3,000+ employees, but still fast, flexible, and hands-on. ✨ Shape the future, sustain growth – Make a difference now *and* build for long-term success. Job Description The Risk & Compliance team ensures Docplanner 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 Docplanner 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 framework, directly supporting one of Docplanner’s core strategic priorities: EU MDR compliance and global expansion. You’ll gain exposure to innovative healthtech and AI-driven products, work with cross-functional teams across multiple markets. How will you make an impact? EU MDR Compliance: Achieve mandatory Medical Device Regulation certification to maintain European market access. Support Global Certification Processes: Lead MDR certification and other accreditation (ISO, C5) processes across target jurisdictions to enable market expansion and continuance. Establish Compliant Governance Framework: Build robust governance systems that stakeholders and customers can trust, ensuring business integrity 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. Qualifications What will help you thrive? 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. Nice 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. Additional Information What to Expect from Our Hiring Process We like to keep 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 first call 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 recharge, we believe in balance. ESOP (Employee Share Option Plan) after 6 months with us—because we believe in sharing our success! 📍 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, develop, and explore new paths—whether within your team or through cross-functional projects. 🌎 A Truly Global Team – Work with talented people from all 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. What We Believe In At Docplanner, our values guide everything we do: 📊 Focus on results – we're here to make an impact. 🧠 Think like an owner – take responsibility, drive outcomes. ✂️ Keep it simple, keep 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—check 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 all 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.

Responsibilities

The Senior Healthcare Regulatory Specialist will ensure compliance with EU Medical Device Regulation and lead certification processes for market expansion. They will also establish governance frameworks and optimize compliance processes to align with regulatory requirements.