Global MedTech Regulatory Specialist

Amaris Consulting; Best; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

International team environment

Diversity & Inclusion

Robust training program

Job summary

Amaris Consulting is seeking a Regulatory Affairs professional to join our international team in the Netherlands. You will drive global product registrations, provide regulatory input across the lifecycle, and support audits and inspections to ensure ongoing compliance.

We require a technically trained candidate with experience in medical devices regulatory submissions (FDA, EU MDR, Health Canada) and strong stakeholder management. English fluency is essential; additional languages are a plus.

Qualifications

• Academic background in a technical field (Bachelor's or Master's).
• Experience in regulatory affairs for medical devices, including global submissions (FDA, Health Canada, EU MDR).
• Experience with regulatory documentation and labeling reviews.
• Strong understanding of global regulatory initiatives and product lifecycle management.

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

Global Submissions

Stakeholder Management

Communication Skills

Education

Technical Bachelor's or Master's

Job description

Amaris Consulting is seeking a Regulatory Affairs professional to join our international team in the Netherlands. You will drive global product registrations, provide regulatory input across the lifecycle, and support audits and inspections to ensure ongoing compliance.

We require a technically trained candidate with experience in medical devices regulatory submissions (FDA, EU MDR, Health Canada) and strong stakeholder management. English fluency is essential; additional languages are a plus.