Experteer Overview In this role you will provide advanced regulatory support for New Product Development, market expansion and sustaining operations across designated business units. You will navigate EU and global medical device regulations and guide cross-functional teams to ensure compliant product development and launches. You’ll manage EMEA registrations, coordinate strategies with stakeholders, and address regulatory inquiries to enable timely approvals. This position offers meaningful impact through general compliance and product lifecycle stewardship.Compensaciones / Beneficios
- Assess regulatory impact in EMEA (EU/EEA, Middle East, Africa) and support market expansion and new product introductions
- Provide regulatory guidance to cross-functional teams to align development with requirements
- Manage preparation, submission, and maintenance of EMEA medical device registration dossiers and ensure timely approvals
- Coordinate registration strategy with Product Lifecycle Management, Supply Chain, Marketing, and Commercial teams
- Prepare and review regulatory correspondence, Letters of Notification, declarations, certificates, and technical documentation
- Monitor sustaining activities including renewals, amendments, and change notifications
- Perform regulatory impact assessments for lifecycle changes (design, labeling, software)
- Maintain registration trackers,



regulatory databases, and product records
- Monitor regulatory changes and update policies to maintain compliance
- Coordinate responses to regulatory authority inquiries and support inspections
- Address inquiries from cross-functional partners with timely, accurate information
- Identify opportunities to improve efficiency, compliance, and process standardization
- Perform other regulatory tasks and projects as assigned across regional marketsResponsabilidades
- Bachelor's or Master's degree in Engineering, Medical Technology, or related field (highly preferred)
- 5+ years in regulatory affairs within the medical device industry
- Proficiency in English with C1 level in speaking and writing
- Experience with medical device registration lifecycle management (registrations, renewals, amendments, change management)
- Experience with regulatory impact assessments and change notification strategies
- Strong knowledge of global regulatory requirements and standards for medical devices (e.G., EU MDR 2017/745, ISO 13485, RoHS)
- Detail-oriented with strong project management and organizational skills
- Ability to lead resolutions across international teams and address project risks
- Proactive, collaborative approach in a team settingRequisitos principales
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📌 Regulatory Affairs Specialist Emea (Madrid)
🏢 Intuitive Surgical
📍 Madrid