Job Title: Regulatory & Compliance Specialist (EU)Location: Netherlands (preferred)Department: International / Regulatory AffairsCompany OverviewSurgerii Robotics is a global medical technology company focused on the R&D, manufacturing, and commercialization of minimally invasive surgical robotic systems and related products.Following nearly 20 years of research, the company has developed a single-port surgical robotic platform featuring an innovative dual continuum mechanism with flexible nitinol instruments.Guided by the mission “Innovating Surgery for Better Care,” Surgerii is expanding globally to advance robotic surgery and support the delivery of high-quality medical care worldwide.------------------------------------------------------------------------------------------------ Position SummaryThe Regulatory & Compliance Specialist will be responsible for managing regulatory interactions with EU competent authorities and notified bodies, ensuring compliance with EU MDR requirements, and supporting market access across European countries.In addition, this role will support communication and education initiatives toward hospitals and clinical partners, particularly regarding reprocessing and sterilization certification, validation documentation, and related regulatory standards.This is a cross-functional role requiring strong regulatory knowledge, communication skills, and the ability to bridge regulatory requirements with commercial and clinical teams.------------------------------------------------------------------------------------------------Key Responsibilities1. Regulatory Affairs & Authority CommunicationServe as the primary liaison with EU competent authorities and relevant regulatory bodiesSupport and coordinate regulatory submissions under EU MDR (2017/745)Work with notified bodies on audits, documentation updates, and compliance mattersMonitor evolving EU medical device regulations and ensure company complianceSupport product registration and regulatory filings in various EU member states2. Compliance ManagementEnsure adherence to EU MDR, ISO 13485, and applicable harmonized standardsSupport internal compliance processes, documentation control, and regulatory reportingCollaborate with Quality, Clinical, and R&D teams to maintain technical documentationAssist with post-market surveillance (PMS) and vigilance reporting activities3. Reprocessing & Sterilization Communication SupportSupport preparation and review of documentation related to cleaning, disinfection, and sterilization validationCommunicate certification and validation information related to reprocessing to hospitals and healthcare providersProvide regulatory clarification and support during hospital onboarding and tender processesWork closely with commercial and clinical teams to ensure accurate representation of regulatory and sterilization compliance information4. Cross-functional CollaborationAct as a regulatory partner to Sales, Clinical, and Market Access teamsSupport regulatory input in tender documentation and technical submissionsAssist in training internal teams on EU regulatory and compliance matters------------------------------------------------------------------------------------------------QualificationsEducation- Bachelor’s or Master’s degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, or related fieldExperienceMinimum 3–5 years of experience in medical device regulatory affairs within the EUStrong knowledge of EU MDR (2017/745)Experience interacting with EU competent authorities and/or notified bodiesFamiliarity with ISO 13485 and quality management systemsExperience with sterilization standards (e.g., ISO 17665, ISO 11135, ISO 11137) is highly desirableExperience with capital equipment or surgical devices is a strong advantageSkillsStrong communication and stakeholder management skillsAbility to translate complex regulatory requirements into clear guidanceOrganized, detail-oriented, and capable of working independentlyFluent in English (additional EU languages are a plus)