Who we are and where we are heading
At Ultra Controlo, we develop engineering solutions for medical and industrial gases that have a real impact. Every day, we work to deliver technology that ensures safety, reliability, and innovation to hospitals and industries worldwide.
We are looking for a Quality and Regulatory Affairs Manager to strengthen our structure and ensure that our medical devices fully comply with all applicable standards and regulatory requirements.
We value professionals with a strong sense of responsibility, high documentary rigor, and the ability to work in regulated environments, who are motivated to grow with us in a demanding and highly technical context.
Your mission
- Implement, maintain, and continuously improve the Quality Management System (ISO 13485, ISO 7396-1, HTM 02-01, MDR), ensuring legal and regulatory compliance.
- Prepare, update, and control MDR technical documentation, register medical devices with Competent Authorities, and manage certifications/CE marking.
- Validate manufacturing orders, supervise testing activities, control and calibrate measurement equipment, and issue Quality Release documentation.
- Ensure full traceability (batches, certificates, records), technical documentation management, and change control processes.
- Coordinate internal and external audits, manage non-conformities, and lead CAPA plans through to proven effectiveness.
- Support Production, Purchasing, and Sales teams; drive regulatory communication; train teams; and monitor quality KPIs.
What we are looking for
- Degree in Engineering (Mechanical, Biomedical, or similar) or Pharmacy, with a minimum of 2 years’ experience in Quality and Regulatory Affairs for Medical Devices;
- nowledgeK of ISO 13485, MDD, and MDR;
- Experience in drafting and reviewing QMS procedures;
- Practical experience in internal and external audits, non-conformity management, and Corrective and Preventive Action plans (CAPA);
- High level of rigor, responsibility, attendance, and punctuality;
- Ability to work autonomously with strong attention to detail;
- Good command of technical English (mandatory).
What we offer
- Competitive salary adjusted to experience and performance;
- Performance bonus and objective-based incentives;
- Stable contract with real career progression opportunities;
- Continuous technical and commercial training;
- Participation in international projects and trade fairs;
- Integration into a solid, collaborative, and innovative team.
At Ultra Controlo, we believe in teams that grow together.
If you are looking for a challenge where quality, regulation, and engineering intersect with real-world impact, we would love to meet you.
Please send your application to [email protected] with the subject:
“Quality and Regulatory Affairs Manager”
Localização do trabalho: Presencial
