Descripción de la oferta
OverviewAt Docplanner Group, we’re on a mission to help people live longer, healthier lives. As the world’s largest healthcare platform, we connect millions of patients with doctors across 13 countries. Our marketplaces, SaaS and AI tools simplify daily tasks and help doctors, clinics and hospitals work more efficiently so they can focus on caring for their patients. Learn more about our products here: pro.doctoralia.esWhy 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 DescriptionThe 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, and 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.QualificationsWhat 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 HaveKnowledge of the EU AI Act.Familiarity with Agile / software development environments.The position is based in Spain and we are remote-friendly.Additional InformationWhat to Expect from Our Hiring ProcessIntro Chat – A first call with our Talent Partner to explore mutual fit around relevant skills, value alignment, and motivation.Business Case – A take-home exercise to understand how you approach real-life problems and regulatory scenarios, followed by a collaborative discussion with the hiring manager and team.Technical Interview – A deeper conversation about your background and experience with EU MDR and compliance, with the potential manager and team.Operational Interview – Discussion focused on operational fit, QMS integration and cross-functional collaboration.Final Interview – A final chat focused on cultural fit, values and strategic alignment.References & OfferWhy You’ll Love It HereGlobal 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.Time off that counts – vacation, birthday, or a day to recharge.ESOP (Employee Share Option Plan) after 6 months with us.Local Perks – Depending on location, local benefits like meal vouchers, transport allowances, or extended parental leave.Career Growth – Opportunities to learn and develop through team or cross-functional projects.A Truly Global Team – Work with talented people from around the world in a diverse and inclusive environment.Flexibility That Works for You – Remote work and flexible hours; office hubs available in Barcelona, Warsaw, Curitiba, Rio de Janeiro, Mexico City, Bogotá, Munich, Rome or Bologna.Please note: We currently cannot sponsor visas for this position. You must have the legal right to work in your country of residence or the location of the role.What We Believe InAt Docplanner, our values guide everything we do:
