EMEA Regulatory Affairs Specialist Madrid

Intuitive Surgical; Madrid; On-site; EUR 70,000 - 90,000; Full time

Job summary

Intuitive Surgical is seeking a Regulatory Affairs Specialist EMEA based in Madrid, Spain, to provide advanced regulatory support for new product development, market expansion, and sustaining operations across designated business units.

You will collaborate with cross-functional teams to ensure regulatory compliance, manage submissions, and stay ahead of evolving medical device regulations across the EMEA region.

Qualifications

• 5+ years of experience in regulatory affairs within medical devices.
• Experience with EU MDR 2017/745, ISO 13485, RoHS and global regulatory requirements.

Responsibilities

• Assess regulatory impact within EMEA and support market expansion and product launches.
• Guide cross-functional teams to ensure regulatory alignment with development changes.
• Prepare, submit, and maintain EMEA medical device registrations and dossiers.
• Coordinate registration strategy with Product Lifecycle Management, Supply Chain, Marketing, and Commercial teams.
• Monitor regulatory changes and update policies to maintain compliance.

Skills

Regulatory affairs

English proficiency (C1+)

Project management

Cross-functional collaboration

Regulatory strategy

Education

Bachelor's or Master's degree in Engineering/Medical Technology or related field

Job description

Intuitive Surgical is seeking a Regulatory Affairs Specialist EMEA based in Madrid, Spain, to provide advanced regulatory support for new product development, market expansion, and sustaining operations across designated business units.

You will collaborate with cross-functional teams to ensure regulatory compliance, manage submissions, and stay ahead of evolving medical device regulations across the EMEA region.