Regulatory Affairs Specialist

As a Regulatory 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 BringRegulatory 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 MandateWithin 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.RequirementsRequired 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 degree 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 as a must (presenting, writing, reading).
• Minimum Years Recommended and / or Preferred :

3-5 years.