Compliance Officer - Spanish en Barcelona, España

We are a healthtech company specialized in the development of advanced robotic surgery systems for high-precision minimally invasive procedures. Founded in 2012 as a spin-off from UPC and IBEC, our mission is to make robot-assisted surgery more accessible, precise, and efficient worldwide. We design and develop next-generation computer-controlled surgical robotic systems and endoscopic instruments.

As a Regulatory Affairs Specialist , you will play a key role in ensuring our medical robotic systems comply with international regulatory requirements throughout the product lifecycle. You will work closely with Quality, Medical Affairs, R&D teams to define regulatory strategies, prepare technical documentation and support the successful approval of our products in Europe, the United States and other international markets.

️ Prepare, maintain and manage Technical Documentation for medical device approvals under MDR, FDA and other applicable regulatory frameworks.
Monitor regulatory changes, standards and guidance documents, performing gap analyses when required.
Review and approve regulatory aspects of commercial materials, including brochures and website content.
Promote a strong quality culture focused on compliance and continuous improvement.

Bachelor's degree in Health Sciences, Biomedical Engineering, Pharmacy, Biology, Chemistry, Engineering or another relevant scientific discipline.
At least 6 years of experience in Regulatory Affairs within the Medical Device industry.
Experience preparing Technical Documentation for medical devices.
Knowledge of European Medical Device Regulation (MDR 2017/745).
Strong understanding of medical device regulations, standards and regulatory guidance.
Professional proficiency in English.
Fluent Spanish (written and spoken).
Advanced Microsoft Office skills and experience working with ERP systems.

Full-time permanent contract.
Flexible working hours.
Hybrid working model.
Continuous learning and professional development in one of the fastest-growing sectors in MedTech.