Regulatory Affairs Engineer

Unity Partners on behalf of our MedTech partnerOur partner is a global MedTech leader developing high-risk Class III medical devices that empower clinicians to deliver personalized, high-quality care. Their mission is simple yet profound: to make cutting-edge treatment accessible to everyone who needs it.To support this mission, we’re looking for a Regulatory Affairs Engineer to join their expanding regulatory team — playing a key role in strengthening global regulatory strategy and ensuring that breakthrough technologies reach patients safely, efficiently, and compliantly across international markets.Key ResponsibilitiesAs a Regulatory Affairs Engineer, you will:Lead and support global regulatory submissions and approvals for key international markets.Translate complex regulatory requirements into practical, actionable business processes.Collaborate cross-functionally with R&D, Manufacturing, Supply Chain, and Quality teams.Serve as the primary liaison with external authorities and notified bodies.Develop, implement, and continuously improve internal regulatory processes and systems.Provide expert input during audits and inspections.Mentor junior regulatory team members and share knowledge across the organization.Stay up to date on international regulatory trends and requirements, including FDA, EU MDR, Health Canada, and APAC regulations.Your ProfileBachelor’s or Master’s degree in Engineering, Life Sciences, or a related technical field.5+ years of experience in regulatory submissions, product registrations, or compliance within the medical device industry.Solid understanding of FDA, EU MDR, ISO 13485, and other global regulatory frameworks.Proven ability to manage complex submissions and cross-functional projects.Strong analytical, problem-solving, and communication skills.Proficiency with Microsoft Office and ERP tools.A proactive, structured, and collaborative mindset.Fluent in English (both written and spoken).Organization & OfferYou’ll join a mission-driven MedTech organisation at the forefront of personalized medical technology. Their work combines engineering excellence with deep clinical purpose — helping healthcare professionals deliver treatments that make a difference when it matters most.Expect:A hybrid work model.A culture built on collaboration, innovation, and integrity.The opportunity to influence global regulatory strategies for life-changing technologies.Competitive compensation, professional development, and international growth opportunities.Interested?If you’re passionate about advancing regulatory excellence in Class III medical devices that truly impact lives, we’d love to hear from you.Reach out to Christian Steenkamp at Unity Partners or send your CV directly via christian@unitypartners.nl