Regulatory Affairs Specialist

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.

• Define and execute regulatory strategies to support product registrations in Europe, the US and other international markets.
• Prepare, maintain and manage Technical Documentation for medical device approvals under MDR, FDA and other applicable regulatory frameworks.
• Analyze regulatory requirements from authorities and Notified Bodies (e.g. MDR, FDA, AEMPS and other international agencies).
• Act as the main point of contact with Notified Bodies, Competent Authorities and regulatory agencies throughout product approval processes.
• Participate in regulatory audits and inspections.
• Prepare and maintain Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER) and support Biological Evaluation Reports (BER).
• Conduct literature reviews to maintain up-to-date state-of-the-art evidence.
• Support vigilance and Post-Market Surveillance (PMS) activities.
• Monitor regulatory changes, standards and guidance documents, performing gap analyses when required.
• Assess the regulatory impact of changes to suppliers, manufacturing processes and products, determining whether submissions to regulatory authorities are 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.

What are we looking for?

• 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).
• Experience interacting with Notified Bodies and Competent Authorities is highly valued.
• Experience with FDA regulatory pathways (510(k), De Novo) is considered a strong advantage.
• Previous experience in the surgical robotics industry will be considered a strong asset.
• Strong understanding of medical device regulations, standards and regulatory guidance.
• Knowledge of MDR 2017/745, RD 192/2023 and relevant standards such as ISO 13485, ISO 14971, ISO 14155, ISO 10993, ISO 11607, ISO 11135, IEC 60601 and related MDCG/FDA guidance documents.
• Excellent analytical and problem-solving skills.
• Strong attention to detail and documentation skills.
• Ability to interpret complex regulations and translate them into practical actions.
• Proactive, organized and collaborative mindset.
• Excellent communication and stakeholder management skills.
• Professional proficiency in English.
• Fluent Spanish (written and spoken).
• Advanced Microsoft Office skills and experience working with ERP systems.

What do we offer?

• Competitive salary aligned with experience.
• Highly innovative environment with real impact on patients' lives.
• Opportunity to work on cutting-edge surgical robotic systems in an international and multidisciplinary team.
• Continuous learning and professional development in one of the fastest-growing sectors in MedTech.