Regulatory Affairs Specialist EMEA

About the role

Intuitive, a leader in robotic-assisted surgery, is hiring a Regulatory Affairs Specialist for its Regulatory Affairs Department in Madrid. The specialist provides advanced regulatory support for New Product Development, market expansion and ongoing operations across designated Business Units, working with cross-functional teams to guide product launches and ensure compliance with EU and global medical device regulations.

Key responsibilities

• Assess regulatory impact in EMEA (EU/EEA, Middle East, Africa) and support new markets, product expansion and new product introductions
• Guide cross-functional teams so product development and changes meet current regulatory requirements
• Manage preparation, submission and maintenance of EMEA medical device registration dossiers
• 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
• Handle renewals, amendments, change notifications and regulatory impact assessments for design changes, labeling updates and software releases
• Maintain registration trackers, regulatory databases and product registration records
• Monitor changes in regulations and standards, update internal policies, and support responses to regulatory authority inquiries and audits
• Support projects that improve efficiency, compliance and process standardization

Required profile

• Bachelor's or Master's degree in Engineering, Medical Technology or a related field is highly preferred; practical experience in a similar role will be considered
• 5+ years of regulatory affairs experience in the medical device industry
• Experience with medical device registration lifecycle (new registrations, renewals, amendments, change management)
• Knowledge of EU MDR 2017/745, ISO 13485, RoHS and other relevant standards
• English at C1 level, written and spoken
• Detail-oriented, with strong project management and organizational skills, and able to lead resolutions across international teams