Lead Regulatory Affairs Specialist

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. With ambitious growth plans and future expansion into new markets, including the United States, this is an opportunity to make a visible impact within a highly innovative environment.

In this role, you will report directly to the QA & RA Director and act as a key regulatory subject matter expert across the business. You will oversee CE Mark maintenance activities, manage Notified Body interactions, assess substantial changes, and support the company's ongoing regulatory strategy as it continues to expand globally.

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. Experience with FDA regulatory processes and higher-risk device classifications would be highly advantageous.

This role is ideal 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.

The Role:

• Own and manage day-to-day Regulatory Affairs activities across the business
• Maintain regulatory compliance and support CE Mark submissions and ongoing certification activities
• Manage communications and relationships with Notified Bodies
• Assess, document, and support regulatory strategies relating to substantial product changes
• Collaborate closely with Medical Affairs, Clinical Studies, Quality, and R&D teams
• Support technical documentation maintenance and ongoing compliance with EU MDR requirements
• Contribute to future FDA regulatory activities as part of the company's international growth strategy

Who We're Looking For:

• Regulatory Affairs experience within the medical device industry
• Strong knowledge of EU MDR requirements and regulatory frameworks
• Experience leading or supporting CE Mark submissions and maintenance activities
• Experience with Class IIb medical devices is essential
• Experience managing Notified Body interactions and post-market regulatory activities
• Can speak Spanish and English

What's On Offer:

• Hybrid and flexible working model
• Opportunity to take ownership of Regulatory Affairs activities
• Exposure to innovative robotic medical technologies
• Collaborative and highly visible position within a growing organisation
• Opportunity to contribute to future US market regulatory activities
• Competitive salary package of €50,000-€65,000