Regulatory Affairs Specialist (Medical Devices)

Location: Utrecht, hybrid working with 3 days onsite
Direct permanent contract with the client, starting with 12 months
 

About the Opportunity

Our client is an international medical device company developing innovative technologies for spinal surgery. Due to continued growth, they are looking for an experienced Regulatory Affairs Specialist to join their Quality & Regulatory Affairs team in the Netherlands.

This role focuses on regulatory submissions, approvals, and lifecycle management across Rest of World (RoW) markets, supporting global expansion for high-risk medical devices.

The Role

Working within the QA/RA team, you will lead regulatory activities for assigned countries and projects, ensuring products remain compliant with international regulations. You'll collaborate closely with internal teams, Notified Bodies, health authorities, distributors, and external consultants.

Key Responsibilities

• Prepare and manage regulatory submissions and registrations for RoW markets.
• Track regulatory approvals and maintain compliance throughout the product lifecycle.
• Assess product and manufacturing changes for regulatory impact.
• Review product labelling and marketing materials for compliance.
• Support the launch of products into new territories, including distributor and regulatory agent setup.
• Provide regulatory guidance to cross-functional teams.
• Lead regulatory activities for assigned projects and coach junior colleagues or external consultants where required.

Requirements

Essential

• Bachelor's degree in Life Sciences, Biomedical Sciences, Engineering, or a related discipline.
• Minimum 5 years' Regulatory Affairs experience within medical devices.
• Experience with high-risk/Class III medical devices.
• Experience with CE marking approvals and worldwide product registrations.
• Strong knowledge of EU MDR/MDD and ISO 13485.
• Experience working with Notified Bodies and international Health Authorities.
• Based in the Netherlands or eligible to work there.

Desirable

• Experience supporting regulatory submissions across multiple international markets.
• Strong project management and stakeholder management skills.
• Experience mentoring junior Regulatory Affairs professionals.

What's on Offer

• Join an innovative international medical device organisation.
• Play a key role in global regulatory activities and international market expansion.
• Collaborative, cross-functional environment with opportunities for professional growth.
• Competitive salary and benefits package.
• Flexible working arrangements.
• Based in the Utrecht region.

If you're an experienced Regulatory Affairs professional looking to broaden your international regulatory experience while making a tangible impact within an innovative medical device company, we'd love to hear from you.