Global MedTech Regulatory Specialist

AMARIS GROUP SA; Netherlands; Remote; EUR 70,000 - 100,000; Full time

Benefits offered by this job

International community

Trust-centered culture

Internal Academy with 250+ modules

Job summary

Amaris Consulting, a fast-growing international firm, seeks a Regulatory Affairs professional for medical devices in the Netherlands. You will provide strategic regulatory input across the product lifecycle, manage global registrations, and monitor changes to maintain compliance in a dynamic, multicultural environment.

The role requires technical degrees, proven experience in global submissions (FDA, Health Canada, EU MDR), and strong communication with stakeholders; English fluency is essential.

Qualifications

• Technical Bachelor and/or Master’s degree.
• Experience in regulatory affairs for medical devices, including global submissions (FDA, Health Canada, EU MDR, etc.).
• Experience with regulatory documentation and labeling reviews.
• Deep understanding of global regulatory and legislative initiatives.
• Knowledge of product lifecycle management and post-market compliance.
• English fluent. Additional languages are a plus.
• Strong communication and stakeholder management skills.
• Comfort navigating audits and regulatory inspections.
• Thrive in a fast-paced, culturally diverse global environment.
• Process-oriented with a proactive mindset.

Responsibilities

• Provide strategic regulatory input throughout the product development lifecycle.
• Support the creation and execution of departmental regulatory strategy plans.
• Manage product registrations and approvals in global markets (FDA, MFDS, NMPA, EU, and others).
• Monitor regulatory procedures and changes to ensure ongoing compliance.
• Play a key role during external audits and notified body inspections.
• Review and recommend updates to labeling and design documentation.
• Report on global regulatory roadmaps and align them with marketing and product strategies.
• Act as a regulatory ambassador, upholding company values and compliance standards.

Skills

Regulatory affairs

English fluency

Communication

Stakeholder management

Education

Technical Bachelor/Master

Job description

Amaris Consulting, a fast-growing international firm, seeks a Regulatory Affairs professional for medical devices in the Netherlands. You will provide strategic regulatory input across the product lifecycle, manage global registrations, and monitor changes to maintain compliance in a dynamic, multicultural environment.

The role requires technical degrees, proven experience in global submissions (FDA, Health Canada, EU MDR), and strong communication with stakeholders; English fluency is essential.