Are you an experienced Regulatory Affairs professional within the medical device industry? Are you looking for a role where you can take ownership of Regulatory Affairs activities, work on innovative robotic medical technologies, and play a key role in supporting international regulatory strategy? On offer is an exciting opportunity to join an innovative medical technology company developing advanced robotic solutions that are transforming surgical procedures.

You will become the regulatory expert within the organisation, taking ownership of day-to-day Regulatory Affairs activities whilst working closely with Quality, Medical Affairs, Clinical Studies, and senior leadership. This company is at the forefront of surgical robotics innovation, developing cutting-edge technology designed to improve patient outcomes and support healthcare professionals worldwide. In this role, you will report directly to the QA & RA Director and act as a key regulatory subject matter expert across the business.

The ideal candidate will bring strong Regulatory Affairs experience within medical devices, a thorough understanding of the EU MDR,



and hands-on experience supporting CE Mark submissions and maintenance. This role is adecuado for Regulatory Affairs professionals looking to take on greater ownership and autonomy within an innovative medical device company, while working closely with cross-functional teams to support the development and commercialisation of life-changing technologies. Own and manage day-to-day Regulatory Affairs activities across the business Maintain regulatory compliance and support CE Mark submissions and ongoing certification activities Collaborate closely with Medical Affairs, Clinical Studies, Quality, and R&D; teams Support technical documentation maintenance and ongoing compliance with EU MDR requirements Regulatory Affairs experience within the medical device industry Experience with Class IIb medical devices is essential Can speak Spanish and English Hybrid and flexible working model Opportunity to take ownership of Regulatory Affairs activities

📌 Regulatory Affairs Manager /Senior Manager (Cataluña)
🏢 Epm Scientific
📍 Cataluña