Regulatory Affairs Specialist

Unity Partners on behalf of our MedTech partnerOur partner is an ambitious and fast-growing medical device company developing a high-risk device. With innovation at its core, the company is building next-generation technology designed to improve patient care. As the organization prepares for further clinical and commercial milestones, they are strengthening their QA/RA capabilities to ensure compliant, scalable, and high-impact product development.As Regulatory Specialist, you’ll be the regulatory backbone of the product development team. You’ll guide cross-functional teams through design controls, risk management, and regulatory documentation, ensuring compliance with international standards (ISO 13485, FDA 21 CFR 820, MDR). This is a critical, hands-on role with high impact—perfect for someone who thrives in a fast-moving, collaborative environment.Key ResponsibilitiesRepresent RA in cross-functional product development teams.Own and improve design control processes: planning, inputs/outputs, verification/validation, and transfer.Write, review, and manage regulatory documentation: DHF, DMR, requirements, test protocols, and more.Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and EU MDR.Participate in design reviews, proactively identifying gaps and risks.Provide expert interpretation of relevant standards, especially in the Class II/III domain.Lead continuous improvement in QMS processes related to design and development.Support CAPA, change control, and risk-based decision-making processes.Your ProfileBachelor's or Master’s degree in Biomedical, Mechanical, Electrical Engineering or a related field.5+ years of relevant experience within the medical device industry.Expertise in design controls, risk management, and relevant regulatory frameworks.Confident communicator with excellent documentation skills.Hands-on, structured, and excited to work in a scaling, impact-driven environment.Organization & OfferYou’ll join a dynamic and forward-thinking MedTech company at a pivotal stage of growth. In this role, you’ll play a vital part in bringing an innovative medical device to market, with real influence over quality and compliance in a regulated development environment. Surrounded by a collaborative international team, you can expect competitive terms, a strong technical mandate, and the opportunity to grow into a senior QA/RA leadership role as the company scales.📩 Want to learn more or apply? Reach out via christian@unitypartners.nl