EMEA Regulatory Affairs Specialist (Medical Devices)

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

Job summary

Intuitive seeks a Regulatory Affairs Specialist to provide advanced regulatory support for NPD, market expansion, and sustaining operations across EMEA. Must master EU MDR, ISO 13485, and RoHS, and lead regulatory submissions with cross-functional teams.

The role requires collaboration with Product Lifecycle Management, Supply Chain, Marketing, and Commercial groups to align regulatory requirements with business goals. Strong project management and global regulatory knowledge are essential.

Qualifications

• Degree in Engineering or Medical Technology; strong regulatory background.

Responsibilities

• Assess regulatory impact for EMEA and support market expansion.

Skills

Regulatory affairs

Project management

Cross-functional collaboration

Attention to detail

English proficiency

Education

Bachelor's or Master's in Engineering

Medical technology background

Tools

Regulatory databases

Documentation management

Job description

Intuitive seeks a Regulatory Affairs Specialist to provide advanced regulatory support for NPD, market expansion, and sustaining operations across EMEA. Must master EU MDR, ISO 13485, and RoHS, and lead regulatory submissions with cross-functional teams.

The role requires collaboration with Product Lifecycle Management, Supply Chain, Marketing, and Commercial groups to align regulatory requirements with business goals. Strong project management and global regulatory knowledge are essential.