Senior Legal Counsel - Medical Device Regulatory Law

Senior Legal Counsel – Medical Device Regulatory Law & Product Classification Location: Germany preferred | or fully remote within the EU A global technology business is seeking a Senior Legal Counsel to provide specialist advice on Medical Device Regulatory Law, software classification and product regulatory strategy.This is a unique opportunity to join a business developing advanced technologies, where you will work closely with Product, Engineering, Regulatory and Commercial teams to assess product classification risks and support the development of innovative software solutions. Key responsibilities:Advise on EU Medical Device Regulation (MDR) and related regulatory frameworksLead legal assessments relating to software classification and intended purposePartner with Product and Engineering teams throughout the product lifecycleReview product features, marketing claims and technical documentation for regulatory implicationsSupport the business in managing medical device regulatory riskAdvise on Software as a Medical Device (SaMD) considerationsMonitor regulatory developments affecting software, AI and digital technologiesDeliver practical, commercially focused legal advice to senior stakeholdersSupport the development of governance processes relating to product compliance and regulatory positioning Requirements:Qualified lawyer admitted in an EU jurisdictionFrom 5 years PQE onwards.Strong expertise in EU Medical Device Regulation (MDR), however, open to broaden your scope to other legal areas such as commercial law, etc.Strong understanding of intended purpose, medical purpose and product classification principlesExperience working with technical, engineering or product teamsExcellent stakeholder management and communication skillsAbility to balance commercial objectives with regulatory requirements Preferred experience:Digital healthHealthcare technologyMedical devicesLife sciences Why consider this opportunity?High-profile role within an innovative technology businessOpportunity to influence regulatory strategy for cutting-edge software productsExposure to AI, digital technologies and emerging regulatory frameworksInternational and collaborative working environmentFlexible location within Europe, with preference for Germany