Regulatory Affairs Consultant (SaMD)

Regulatory Affairs Consultant – Software as a Medical Device (SaMD)

Direct Contract (initially starting with 12-Months) | Hybrid (Netherlands) | Minimum 3 Days per Week

We're partnering with a growing Dutch consultancy specialising in Regulatory Affairs, Quality, and Clinical support for innovative MedTech and Digital Health companies. Due to continued growth, we're looking for an experienced Regulatory Affairs Consultant with strong expertise in Software as a Medical Device (SaMD) to support a portfolio of startup and scale-up clients.

This is an ideal opportunity for someone who enjoys variety, thrives in fast-paced environments, and wants to work closely with innovative companies bringing cutting-edge medical software to market.

The Role

You'll work directly with clients, taking ownership of regulatory activities across multiple projects. A large part of the role focuses on creating, reviewing, and maintaining technical documentation from scratch, supporting products through regulatory submissions and market access.

You'll act as a trusted advisor to clients, balancing technical regulatory expertise with a pragmatic consultancy approach.

Responsibilities

• Develop and review technical documentation for Software as a Medical Device (SaMD)
• Support clients throughout the product lifecycle, from development through CE marking and regulatory submissions
• Provide regulatory guidance across European and/or US markets
• Interpret and apply relevant standards and regulations
• Work directly with startup founders, engineering teams, quality teams, and other stakeholders
• Support regulatory strategies tailored to innovative digital health products
• Contribute to multiple client projects simultaneously in a consultancy environment

What We're Looking For

Essential

• Experience in Regulatory Affairs for Software as a Medical Device (SaMD)
• Proven experience writing and reviewing technical documentation from scratch
• Knowledge of EU MDR and/or US FDA regulatory pathways
• Experience with medical software standards including IEC 62304; IEC 81001-5-1
• Experience supporting Class IIa and/or Class IIb medical devices
• Comfortable managing client relationships independently
• Excellent communication skills with a consultative mindset
• Able to adapt quickly within startup and scale-up environments

Desirable

• Experience with AI and Machine Learning-enabled medical devices
• Quality Management Systems and audit experience
• Consultancy experience

What's on Offer

• Minimum commitment of 3 days per week, full-time preferred
• Flexible hybrid working with limited travel
• Performance bonus
• Opportunity to work with innovative MedTech and Digital Health companies across Europe
• High level of autonomy and exposure to diverse regulatory projects

If you're an experienced SaMD Regulatory Affairs professional looking for a varied consultancy role supporting innovative medical software companies, we'd love to hear from you.

Apply today or reach out for a confidential discussion.