Regulatory Affairs Specialist – Medical Devices (SaMD)

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    "description": "<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\"><span style=\"font-weight: bold\">Location:</span> Lisbon, Portugal (Hybrid options available)  </span></p>\n<p><br></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\"><span style=\"color: rgb(15, 71, 97); font-weight: bold\">About UpHill </span><span style=\"color: rgb(15, 71, 97)\"> </span></span></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">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.  </span></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">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 <span style=\"font-weight: bold\">Uphiller</span>. </span></p>\n<p><br><br></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Today, we are looking for a <span style=\"font-weight: bold\">Regulatory Affairs Specialist</span> to <span style=\"font-weight: bold\">build, own and operate</span> our regulatory and quality framework.</span></p>\n<p><span style=\"font-size: 12pt\"><br></span><br></p>\n<p><span style=\"font-size: 12pt\"><span style=\"font-weight: bold\">What you will do</span></span></p>\n<p><span style=\"font-size: 12pt\">Own the regulatory system</span></p>\n<ul>\n<li><span style=\"font-size: 12pt\">Build, maintain and scale our <span style=\"font-weight: bold\">regulatory and quality framework</span></span></li>\n<li><span style=\"font-size: 12pt\">Ensure compliance with:</span>\n<ul>\n<li><span style=\"font-size: 12pt\">EU MDR (Medical Device Regulation)</span></li>\n<li><span style=\"font-size: 12pt\">UKCA (United Kingdom Conformity Assessed marking)</span></li>\n<li><span style=\"font-size: 12pt\">FDA (Food and Drug Administration, US) requirements for SaMD</span></li>\n</ul>\n</li>\n<li><span style=\"font-size: 12pt\">Act as PRRC (Person Responsible for Regulatory Compliance) or prepare to formally assume this role</span></li>\n<li><span style=\"font-size: 12pt\">Own and maintain high quality technical files and documentation</span></li>\n<li><span style=\"font-size: 12pt\">Be the main point of contact with NB (Notified Body) and auditors</span></li>\n</ul>\n<p><span style=\"font-size: 12pt\">Run the Quality Management System</span></p>\n<ul>\n<li><span style=\"font-size: 12pt\">Design, operate and continuously improve the QMS (Quality Management System) under ISO 13485 (Medical Device Quality Management)</span></li>\n<li><span style=\"font-size: 12pt\">Plan and run internal audits</span></li>\n<li><span style=\"font-size: 12pt\">Prepare and lead external audits</span></li>\n<li><span style=\"font-size: 12pt\">Manage Corrective and Preventive Actions</span></li>\n</ul>\n<p><span style=\"font-size: 12pt\">Work inside the product team</span></p>\n<ul>\n<li><span style=\"font-size: 12pt\">Work daily with:</span>\n<ul>\n<li><span style=\"font-size: 12pt\">Engineering (SDLC – Software Development Life Cycle, validation, traceability)</span></li>\n<li><span style=\"font-size: 12pt\">Product and clinical teams</span></li>\n<li><span style=\"font-size: 12pt\">Customer-facing teams</span></li>\n</ul>\n</li>\n<li><span style=\"font-size: 12pt\">Translate regulatory requirements into practical product and process requirements</span></li>\n<li><span style=\"font-size: 12pt\">Create and deliver training and guidance for teams</span></li>\n</ul>\n<p><span style=\"font-size: 12pt\">Security &amp; data</span></p>\n<ul>\n<li><span style=\"font-size: 12pt\">Support compliance related to ISO 27001 (Information Security Management Systems), cybersecurity and data protection for medical software</span></li>\n</ul>\n<p><span style=\"font-size: 12pt\"><br></span></p>\n<p><span style=\"font-size: 12pt\"><span style=\"font-weight: bold\">Who we are looking for</span></span></p>\n<p><span style=\"font-size: 12pt\">We are looking for someone who has already worked <span style=\"font-weight: bold\">inside a medical device manufacturer</span>, ideally in <span style=\"font-weight: bold\">software or digital health</span>, and who is comfortable building things from scratch.</span></p>\n<p><br></p>\n<p><span style=\"font-size: 12pt; font-weight: bold\">Required</span></p>\n<ul>\n<li><span style=\"font-size: 12pt\">3+ years of experience in <span style=\"font-weight: bold\">Regulatory Affairs, Quality or Compliance</span> in a <span style=\"font-weight: bold\">medical device company</span></span></li>\n<li><span style=\"font-size: 12pt\">Practical experience with:</span>\n<ul>\n<li><span style=\"font-size: 12pt; font-weight: bold\">EU MDR (Medical Device Regulation)</span></li>\n<li><span style=\"font-size: 12pt; font-weight: bold\">ISO 13485</span></li>\n<li><span style=\"font-size: 12pt; font-weight: bold\">Technical documentation and audits</span></li>\n</ul>\n</li>\n<li><span style=\"font-size: 12pt\">Eligibility (or a clear path) to act as <span style=\"font-weight: bold\">PRRC (Person Responsible for Regulatory Compliance)</span></span></li>\n<li><span style=\"font-size: 12pt\">Experience working with <span style=\"font-weight: bold\">NBs (Notified Bodies)</span></span></li>\n<li><span style=\"font-size: 12pt\">Comfortable working with engineers and product teams</span></li>\n<li><span style=\"font-size: 12pt\">Fluent English</span></li>\n</ul>\n<p><br></p>\n<p><span style=\"font-size: 12pt; font-weight: bold\">Nice to have</span></p>\n<ul>\n<li><span style=\"font-size: 12pt\">Experience with <span style=\"font-weight: bold\">SaMD (Software as a Medical Device)</span></span></li>\n<li><span style=\"font-size: 12pt\">Exposure to <span style=\"font-weight: bold\">FDA (US)</span> and <span style=\"font-weight: bold\">UKCA</span></span></li>\n<li><span style=\"font-size: 12pt\">Knowledge of <span style=\"font-weight: bold\">ISO 27001</span> and medical software cybersecurity</span></li>\n<li><span style=\"font-size: 12pt\">Startup, scale-up or early-stage company experience</span></li>\n</ul>\n<p><br></p>\n<p><span style=\"font-weight: bold\"><span>What You’ll Get</span></span><span> </span></p>\n<ul>\n<li><span>Be part of a mission-driven team shaping the future of healthcare</span><span> </span></li>\n</ul>\n<ul>\n<li><span>Competitive salary</span><span> </span></li>\n</ul>\n<ul>\n<li><span>Flexible work options</span><span> </span></li>\n</ul>\n<ul>\n<li><span>Comprehensive health insurance</span><span> </span></li>\n</ul>\n<ul>\n<li><span>Top-tier equipment – new PC plus budget for peripherals</span><span> </span></li>\n</ul>\n<ul>\n<li><span>A no-BS culture built on trust, impact, and collaboration</span><span> </span></li>\n</ul>\n<p><span> </span></p>\n<p><span style=\"font-weight: bold\"><span>Ready to support the transformation of healthcare with us?</span></span><span> <br></span><span>Apply now and become an Uphiller!</span><span> </span></p>",
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