Regulatory Affairs

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

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)