Regulatory Affairs
Unilabs
- Employment
- Full-time
About the 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 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)
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