Regulatory Specialist and Senior Specialist
hace 5 días
Apply for this job At the Vitrolife Group, we work every day to unlock the full potential of science and technology to reduce the barriers towards building a family. Vitrolife Group is a global provider of medical devices and genetic services. Based on science and advanced research capabilities, we develop services and products for personalized genetic information and medical device products. As Regulatory Affairs Specialist, you will lead regulatory initiatives across product development, manufacturing, and distribution. You'll liaise with regulatory authorities, support global sales growth through new product registrations and ongoing regulatory maintenance. You'll thrive in a collaborative environment alongside highly skilled and dedicated colleagues. Whether managing regulatory affairs projects or diving deep into country-specific regulatory standards, your adaptability and interpersonal skills will be key to success. This role focuses on ensuring our products and genetic services meet global regulatory requirements throughout the product lifecycle – from development through commercialization – in close collaboration with our post‐market surveillance team. Compliance Monitoring: Ensure ongoing compliance with regulations across Europe, the Middle East and Africa (e.g., CE marking under IVDR, local registrations, etc.) for new and existing IVD products and lab‐developed tests (LDTs). Cross‐functional Collaboration: Work closely with R&D, Quality Assurance, Clinical Affairs, and Marketing to support regulatory strategies and product development. Monitor changes in global regulatory landscapes and assess their impact on company products and processes. Hold a Bachelor's or Master's degree in biology, chemistry, physics, or equivalent or experience in regulatory affairs for ART. Bring 2–5 years of experience in regulatory affairs, preferably within the IVD or medical device industry. Curious and passionate about regulatory affairs with a technical interest in genetic services. Fluent in both Spanish and English. RAC (Regulatory Affairs Certification) is a plus. Experience with software‐based IVDs or IEC 62304 is highly desirable. Enjoy a competitive salary, benefits, and support for ongoing professional development. Vitrolife Group's products and services are available in more than 125 countries, through our own presence in more than 25 countries and a network of distributors. Department: Quality & Regulatory Remote status: Hybrid Full‐time
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