Unilabs

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Regulatory Affairs @ Unilabs

Porto, PortugalOnsiteFull-timePosted 1 days ago

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About this role

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 ERSInteract with regulatory authorities (ERS and INFARMED when applicable)Prepare and submit licensing, modification and renewal requestsSupport and follow up on inspections, audits and regulatory proceedings, in liaison with LegalSupport licensing and compliance aspects in new unit openings and operational projectsEnsure continuous follow-up of regulatory obligations and pending topicsMaintain and organise regulatory documentation and licensing recordsCoordinate with internal stakeholders (Operations, Quality, Legal, Infrastructure)Provide guidance to operational teams on regulatory requirementsIdentify and track regulatory risks, ensuring timely mitigation

Requirements

Qualifications

2–5 years of experience in regulatory / administrative rolesExperience with public authorities and administrative processes (ERS experience preferred)Strong organisation, follow-up and ownership capabilitiesAble to work autonomously and interact with multiple stakeholdersDegree in relevant field (life sciences / health related – preferred, not mandatory)

Skills

Legal

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Regulatory Affairs at Unilabs | ResuMinder Jobs