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RA Consultant SaMD
Panda International B.V.
About the role
Regulatory Affairs Consultant – Software as a Medical Device (SaMD)
Direct (Perm starting with 12-month) Contract | 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 Software as a Medical Device (SaMD) expertise 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.
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.
What you'll do
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 you'll bring
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 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
Experience with medical software standards including:
IEC 62304
IEC 81001-5-1
What's on offer
Initial 12-month contract with strong extension potential
Minimum commitment of 3 days per week, full-time preferred
Flexible hybrid working with limited travel
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.