Regulatory Affairs Specialist – Medical Devices (SaMD)

Location: Lisbon, Portugal (Hybrid options available) About UpHill At UpHill, we’re on a mission to revolutionize healthcare. By developing best-practice clinical pathways and care orchestration software, we help healthcare providers and life sciences companies across Europe streamline their processes, eliminate inefficiencies, and increase care coordination, which results in improve outcomes for patient — all while creating more capacity for health systems and enabling high quality healthcare healthcare to be delivered more cost effectively. We’re not just another healthtech company; we have built the most compliance-ready care orchestration solution in Europe. We’re a team of innovators who push boundaries, take ownership, and strive for excellence. If you’re excited about making a real impact, growing alongside passionate colleagues, and tackling meaningful challenges, you just might be an Uphiller . Today, we are looking for a Regulatory Affairs Specialist to build, own and operate our regulatory and quality framework. What you will do Own the regulatory system Build, maintain and scale our regulatory and quality framework Ensure compliance with: EU MDR (Medical Device Regulation) UKCA (United Kingdom Conformity Assessed marking) FDA (Food and Drug Administration, US) requirements for SaMD Act as PRRC (Person Responsible for Regulatory Compliance) or prepare to formally assume this role Own and maintain high quality technical files and documentation Be the main point of contact with NB (Notified Body) and auditors Run the Quality Management System Design, operate and continuously improve the QMS (Quality Management System) under ISO 13485 (Medical Device Quality Management) Plan and run internal audits Prepare and lead external audits Manage Corrective and Preventive Actions Work inside the product team Work daily with: Engineering (SDLC – Software Development Life Cycle, validation, traceability) Product and clinical teams Customer-facing teams Translate regulatory requirements into practical product and process requirements Create and deliver training and guidance for teams Security & data Support compliance related to ISO 27001 (Information Security Management Systems), cybersecurity and data protection for medical software Who we are looking for We are looking for someone who has already worked inside a medical device manufacturer , ideally in software or digital health , and who is comfortable building things from scratch. Required 3+ years of experience in Regulatory Affairs, Quality or Compliance in a medical device company Practical experience with: EU MDR (Medical Device Regulation) ISO 13485 Technical documentation and audits Eligibility (or a clear path) to act as PRRC (Person Responsible for Regulatory Compliance) Experience working with NBs (Notified Bodies) Comfortable working with engineers and product teams Fluent English Nice to have Experience with SaMD (Software as a Medical Device) Exposure to FDA (US) and UKCA Knowledge of ISO 27001 and medical software cybersecurity Startup, scale-up or early-stage company experience What You’ll Get Be part of a mission-driven team shaping the future of healthcare Competitive salary Flexible work options Comprehensive health insurance Top-tier equipment – new PC plus budget for peripherals A no-BS culture built on trust, impact, and collaboration Ready to support the transformation of healthcare with us? Apply now and become an Uphiller!