REGULATORY AFFAIRS MANAGER – MEDICAL DEVICES

We are looking for a proactive Regulatory Affairs Manager with a strong background in medical devices regulatory affairs, ideally within the context of oncology and/or neurology. The successful candidate will lead the regulatory strategy and execution from preclinical development to clinical trials, ensuring compliance with the European Medical Device Regulation (EU MDR 2017/745).

He/She will also take the lead in designing and implementing a Quality Management System (QMS) compliant with ISO 13485, to support our development and clinical programs. 

This is a high impact role reporting directly to the leadership team, offering the opportunity to shape both the regulatory and quality of the company as we grow.

Key Responsibilities

• Develop and implement regulatory strategies for Class III medical devices, specifically in glioblastoma treatment.
• Lead all regulatory activities from early development (preclinical) through to clinical trial applications and beyond.
• Prepare, review, and submit documentation required for regulatory approvals, including Clinical Investigation Applications, Technical Documentation, and CE marking submissions under EU MDR.
• Serve as the main point of contact with regulatory authorities (e.g., Spanish Regulatory Agency AEMPS, Notified Bodies, etc).
• Design, implement, and maintain a QMS aligned with ISO 13485 standards, in collaboration with internal stakeholders.
• Develop and manage QMS documentation, including SOPs, work instructions, and training records.
• Ensure internal processes and development activities are aligned with QMS and regulatory requirements.
• Monitor changes in the regulatory landscape (EU MDR and international standards) and assess their impact on projects.
• Collaborate cross-functionally with R&D, Quality, Clinical, and Manufacturing teams to ensure alignment with regulatory requirements, as well as with external CROs/consultants.
• Support clinical trials by ensuring compliance with relevant guidelines (ISO 14155, ICHGCP, etc.).
• Ensure all regulatory activities are conducted according to timelines and budgets.

Qualifications

• Bachelor's or Master’s degree in Life Sciences, Medicine, Biomedical Engineering or related field.
• Minimum 3 years of experience (5+ years preferred) in a similar regulatory affair role in the biotech or medical device industry, preferably with Class III devices.
• Proven experience with EU MDR 2017/745, including preparation of technical documentation and submissions for CE marking.
• Strong understanding of the clinical and regulatory requirements for high-risk (Class III) devices, especially those used in oncology or neurology.
• Experience in leading regulatory submissions for clinical investigations (first-in-human studies a plus).
• Knowledge of preclinical study requirements and interface with regulatory bodies during early development phases.
• Excellent project management, communication, and leadership skills.
• Fluent in English; additional European languages (Spanish) are a plus.

What We Offer

• The chance to join a young, ambitious, and fast-growing company with a mission to revolutionize cancer treatment.
• A dynamic and collaborative work environment where your voice matters and where you will have a direct impact on strategic decisions.
• A clear path for professional growth and leadership development as the company scales.
• Competitive salary, depending on experience.
• Performance-based incentives, including the possibility of phantom shares or other equity-linked benefits aligned with company milestones and growth.
• Flexible working arrangements (remote, hybrid, or on-site) and a supportive team
  culture.