04 ago
|
Docplanner
|
Barcelona
04 ago
Docplanner
Barcelona
ph3Overview /h3pAt 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.es /ph3Why join us? /h3pReal impact – We help doctors help patients. Your work truly makes a difference. /ppAt scale, yet agile – 3,000+ employees, but still fast, versátil, and hands-on. /ppShape the future, sustain growth – Make a difference now and build for long-term success. /ph3Job Description /h3pThe 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. /ppWe are hiring a bSenior Healthcare Regulatory Specialist (SaMD) /b 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. /ppThis 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. /ph3How will you make an impact? /h3ulliEU MDR Compliance: Achieve mandatory Medical Device Regulation certification to maintain European market access. /liliSupport Global Certification Processes: Lead MDR certification and other accreditation (ISO, C5) processes across target jurisdictions to enable market expansion and continuance. /liliEstablish Compliant Governance Framework:
Build robust governance systems that stakeholders and customers can trust, ensuring business integrity and regulatory adherence. /liliRisk Mitigation Business Protection: Prevent regulatory fines and reputational harm that could impact our ability to serve patients and healthcare providers. /liliProcess Optimization: Continuously assess and improve compliance processes to align with the dynamic needs of the increasingly regulated digital healthcare industry. /li /ulh3Qualifications /h3h3What will help you thrive? /h3ulliStrong knowledge of EU Medical Device Regulation (MDR), particularly in a Software as a Medical Device (SaMD) context. /liliPractical experience in medical device regulatory affairs and solid understanding of Quality Management Systems (QMS) and regulatory governance frameworks. /liliRelevant academic background (law, medicine, pharmacy, engineering, or scientific field) or the equivalent hands-on experience in medical device regulatory/QMS experience. /liliExperience with EUDAMED, CAPA systems, and post-market surveillance tools. /liliAbility to manage cross-functional regulatory projects independently and work with multiple stakeholders. /liliStrong communication skills with both internal teams and external regulatory authorities. /liliFluent in English; Spanish or other EU languages are a plus. /li /ulh3Nice To Have /h3ulliKnowledge of the EU AI Act. /liliFamiliarity with Agile / software development environments. /li /ulpThe position is based in Spain and we are remote-friendly. /ph3Additional Information /h3h3What to Expect from Our Hiring Process /h3ollibIntro Chat /b – A first call with our Talent Partner to explore mutual fit around relevant skills, value alignment, and motivation. /lilibBusiness Case /b – 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.
/lilibTechnical Interview /b – A deeper conversation about your background and experience with EU MDR and compliance, with the potential manager and team. /lilibOperational Interview /b – Discussion focused on operational fit, QMS integration and cross-functional collaboration. /lilibFinal Interview /b – A final chat focused on cultural fit, values and strategic alignment. /lilibReferences Offer /b /li /olh3Why You’ll Love It Here /h3pbGlobal Benefits /b – No matter where you are, you’ll have access to: /pulliHealthcare insurance – so you can focus on what matters. /liliWellness that works for you – from gym memberships to mental health support. /liliTime off that counts – vacation, birthday, or a day to recharge. /liliESOP (Employee Share Option Plan) after 6 months with us. /li /ulpbLocal Perks /b – Depending on location, local benefits like meal vouchers, transport allowances, or extended parental leave. /ppbCareer Growth /b – Opportunities to learn and develop through team or cross-functional projects. /ppbA Truly Global Team /b – Work with talented people from around the world in a diverse and inclusive environment. /ppbFlexibility That Works for You /b – Remote work and flexible hours; office hubs available in Barcelona, Warsaw, Curitiba, Rio de Janeiro, Mexico City, Bogotá, Munich, Rome or Bologna. /ppemPlease note: /em 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. /ph3What We Believe In /h3pAt Docplanner, our values guide everything we do: /ppb Focus on results – /b we’re here to make an impact. /ppb? Think like an owner – /b take responsibility and drive outcomes. /ppb✂️ Keep it simple, keep it lean – /b smart solutions over complexity. /ppb Be respectful and radically honest – /b openness builds trust. /ppb Learn and be curious – /b growth is part of the job. /ppDon’t just take our word for it—check out our Glassdoor to hear what our people say! /ppWe are committed to building a team that represents a variety of backgrounds, perspectives, and skills. We welcome applicants from all walks of life, and are dedicated to fostering an inclusive workplace where everyone feels valued and empowered to contribute. /p /p #J-18808-Ljbffr
📌 Senior Healthcare Regulatory Specialist (saMD) - (Remote-friendly within Spain)
🏢 Docplanner
📍 Barcelona