Global Regulatory Affairs Manager – Medical Devices

Laborie; Hengelo; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance group discounts

Company car where applicable

Pension plan

Paid time off and volunteer time

Job summary

Laborie is seeking a Regulatory Affairs Manager to lead regulatory programs for multiple product lines across EMEA, LATAM and other international markets. You will develop and execute strategies, guide cross-functional teams through development and commercialization, and manage submissions and market access activities.

The role requires strong English communication, 7+ years in regulatory affairs for medical devices, and experience with EU MDR (2017/745).

Qualifications

• Excellent written and verbal communication skills in English.
• Strong project management, analytical, and problem-solving skills.
• Experience interacting with regulatory authorities and notified bodies.
• Experience working within a regulated quality management system environment.
• 7+ years regulatory affairs experience in medical devices.

Responsibilities

• Act as the primary regulatory lead for multiple product lines and regions.
• Develop and execute international regulatory strategies for new products, changes, and lifecycle management.
• Lead regulatory submissions, registrations, renewals, and market access activities across EMEA, LATAM, and other regions.

Skills

Project management

Analytical thinking

Problem solving

English communication

Education

Bachelor's degree in Engineering/ Life Sciences/ Biomedical Sciences/ Regulatory Affairs

Job description

Laborie is seeking a Regulatory Affairs Manager to lead regulatory programs for multiple product lines across EMEA, LATAM and other international markets. You will develop and execute strategies, guide cross-functional teams through development and commercialization, and manage submissions and market access activities.

The role requires strong English communication, 7+ years in regulatory affairs for medical devices, and experience with EU MDR (2017/745).