As aRegulatory Specialist, you will play a vital role in ensuring Unilabs' compliance with the In Vitro Diagnostic Medical Devices Regulation (EU) 2017 / 746 (IVDR) and equivalent frameworks across our laboratories in Europe. You’ll work cross-functionally to embed a culture of regulatory excellence and support regulatory oversight for projects, technical documentation, and compliance strategies.Why Join Unilabs?
Unilabs is a leading diagnostic services provider at the forefront of integrated healthcare. Join a collaborative team where your regulatory expertise will directly impact patient safety, product compliance, and business success across Europe.What You Bring
Regulatory Strategy & Culture
Promote a strong culture of regulatory compliance through training, communication, and support.Educate internal stakeholders on regulatory fundamentals, programs, and tools related to product safety and performance.Regulatory Compliance & Documentation
Support the implementation and maintenance of IVDR and equivalent frameworks (e.G., IvDO).Assist in preparing and auditing Technical File dossiers across Unilabs units.Develop and maintain policies, procedures, and documentation related to product regulatory compliance.Perform regulatory assessments for suppliers and new business initiatives.Maintain the UL Regulatory Excellence tool, coordinating with country QARA to ensure accurate records and data integrity.Monitoring & Continuous Improvement
Support training and onboarding related to new or updated regulatory procedures.Contribute to regulatory reviews across markets and drive continuous improvement initiatives.Business Integration & Support
Set up and monitor regulatory intelligence systems.Support the local implementation of global initiatives to ensure alignment and compliance.Conduct regulatory assessments for local projects and business decisions.Decision-Making Mandate
Within the scope of your role, you are empowered to:
Advise teams on the regulatory implications of planned activities or services.Recommend compliance risk mitigation actions.Escalate issues involving significant regulatory risk or business impact.Required Capabilities
Strong understanding of IVDR and other relevant regulatory frameworks.Skilled in the preparation and review of technical documentation.Critical thinking and problem-solving skills in a regulatory context.Self-motivated, detail-oriented, and capable of working cross-functionally.Strong written and verbal communication skills in English (Spanish is a plus).Education & Experience
Bachelor’s or master’s degree in technical/process engineering, QA, Medical Device discipline, with significant related professional experience within the laboratory environment.Experience with medical device regulation and/or in-vitro diagnostic regulation.English fluent (presenting, writing, reading) is mandatory.Minimum 3-5 years of relevant experience preferred.
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