Company Description
Ultra Controlo is dedicated to improving healthcare infrastructure worldwide, striving to build innovative and high-quality solutions for better patient care. We aim to contribute to a healthier and brighter future for everyone by delivering excellence and reliability in healthcare systems. By being part of our team, you join a mission to create impactful solutions that prioritize quality and well-being.
Role Description
This is a full-time on-site role for a Quality and Regulatory Affairs Manager based in Sintra. The chosen candidate will lead and oversee quality management and regulatory compliance activities. Day-to-day tasks include developing and implementing quality control systems, ensuring compliance with regulatory standards, preparing and maintaining documentation, conducting internal audits, and liaising with regulatory authorities. Collaboration with cross-functional teams to ensure product and process compliance is a key aspect of this role.
Qualifications
* Proficiency in Quality Control, Quality Management Systems, and compliance with industry standards and regulations.
* Experience in Regulatory Affairs, including preparing regulatory submissions and maintaining compliance with applicable legal requirements.
* Strong organizational skills, attention to detail, and the ability to lead internal audits and solve quality-related issues effectively.
* Excellent written and verbal communication skills in English and Portuguese.
* Proficiency with documentation management and reporting tools.
* Bachelor's degree in Engineering, Life Sciences, or a related field. Advanced certifications in Quality or Regulatory Affairs are advantageous.
* Familiarity with healthcare or medical device industry regulations is a strong plus.