Regulatory Affairs

Description

Summary: This role involves ensuring efficient execution and follow-up of licensing processes and regulatory obligations for healthcare units in Portugal. Highlights: 1. Manage licensing processes of healthcare units with ERS 2. Interact with regulatory authorities (ERS and INFARMED) 3. Support licensing and compliance in new unit openings **About Unilabs** Headquartered in Geneva and part of the A.P. Moller Group, Unilabs is one of Europe’s leading medical diagnostics companies, offering a complete range of laboratory, pathology, genetics, and imaging services to patients across 14 countries. Unilabs invests heavily in technology, equipment, and people – using digital technologies in its state\-of\-the\-art laboratories and imaging institutes – to improve the lives of close to 100 million people every year. **About the Role** Ensure efficient execution and follow\-up of licensing processes and regulatory obligations for healthcare units in Portugal, supporting operations and maintaining full regulatory compliance. **Responsabilities** * Manage licensing processes of healthcare units with ERS * Interact with regulatory authorities (ERS and INFARMED when applicable) * Prepare and submit licensing, modification and renewal requests * Support and follow up on inspections, audits and regulatory proceedings, in liaison with Legal * Support licensing and compliance aspects in new unit openings and operational projects * Ensure continuous follow\-up of regulatory obligations and pending topics * Maintain and organise regulatory documentation and licensing records * Coordinate with internal stakeholders (Operations, Quality, Legal, Infrastructure) * Provide guidance to operational teams on regulatory requirements * Identify and track regulatory risks, ensuring timely mitigation **Requirements** **Qualifications** * 2–5 years of experience in regulatory / administrative roles * Experience with public authorities and administrative processes (ERS experience preferred) * Strong organisation, follow\-up and ownership capabilities * Able to work autonomously and interact with multiple stakeholders * Degree in relevant field (life sciences / health related – preferred, not mandatory)