Regulatory Specialist

Regulatory Specialist 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. 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. 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.