EMEA Regulatory Affairs Lead - Medical Devices

Intuitive; Madrid; On-site; EUR 90,000 - 130,000; Full time

Job summary

Intuitive is seeking a Sr. Regulatory Affairs Specialist EMEA to lead regulatory strategy across Europe, the Middle East, and Africa. You will steer registrations, sustain activities, and collaborate with cross‑functional partners to align regulatory requirements with business goals.

The role demands deep knowledge of global medical device regulations and strong project management expertise to support product launches and ongoing compliance in a fast‑paced environment.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Medical Technology, or related field preferred or considered with relevant experience.
• Proficiency in English with minimum C1 level in writing and speaking.
• 8+ years of regulatory affairs experience in the medical device industry, including EU MDR/ISO 13485 familiarity.

Responsibilities

• Lead regulatory strategy for new markets and product expansions in EMEA.
• Manage registration dossiers, renewals, amendments, and change notifications.
• Provide direction on regulatory requirements and coordinate cross‑functional teams.

Skills

Regulatory affairs

English (C1)

Education

Bachelor’s or Master’s in Engineering/Medical Technology or related field

Job description

Intuitive is seeking a Sr. Regulatory Affairs Specialist EMEA to lead regulatory strategy across Europe, the Middle East, and Africa. You will steer registrations, sustain activities, and collaborate with cross‑functional partners to align regulatory requirements with business goals.

The role demands deep knowledge of global medical device regulations and strong project management expertise to support product launches and ongoing compliance in a fast‑paced environment.