HEAD OF QA/RA

Our client is a dynamic and innovative company in the medical devices sector, currently seeking an experienced and proactive Head of Quality & Regulatory Affairs to lead and scale their Quality & Regulatory team.

With a strong commitment to improving diagnostics in women's health, the company has also been widely recognized for its innovation, receiving multiple awards in the healthcare technology space.

They have offices in Bilbao, Madrid, and Barcelona and operate under a hybrid work model.

This is a key leadership position where the successful candidate will define and execute regulatory strategies, ensuring compliance with EU MDR (Class II) and FDA (Class III) requirements. Additionally, the role involves driving the development and maintenance of a robust Quality Management System (QMS) aligned with ISO 13485 and other applicable standards.

As part of this exciting opportunity, the Head of QARA will be at the forefront of shaping the regulatory and quality landscape of the company. The role requires someone who can adapt quickly to the challenges, while ensuring compliance with all regulatory standards and fostering a culture of continuous improvement.

Main Functions and Responsibilities:

Regulatory Affairs (RA) – Ensuring Compliance & Market Approval:

• Regulatory Strategy Development: Define and execute strategies for obtaining regulatory approvals in EU (MDR, Class II) and US (FDA, Class III).
• Submission & Approval Process: Lead CE marking, 510(k)/PMA submissions.
• Regulatory Interfacing: Act as the main contact with Notified Bodies, FDA, and other regulatory agencies.
• Technical Documentation: Prepare and maintain Technical Files, Design Dossiers, and GSPR compliance documents.
• Clinical & Post-Market Compliance: Ensure compliance with clinical evaluation (CER) and post-market surveillance (PMS).
• Regulatory Intelligence: Stay up to date with evolving regulations, guiding the company on compliance risks and opportunities.

Quality Assurance (QA) – Managing QMS:

• QMS Maintenance: Develop and maintain an ISO 13485-compliant Quality Management System aligned with FDA QSR (21 CFR Part 820).
• Audit & Inspection Readiness: Lead internal, external, Notified Body, and FDA audits.
• Risk Management & CAPA: Oversee risk management (ISO 14971), CAPA (Corrective and Preventive Actions), and non-conformance handling.
• Supplier & Manufacturing Quality: Supervise supplier qualification, audits, and incoming quality control processes.
• Complaint Handling & Post-Market Surveillance: Ensure effective processes for tracking and addressing adverse events, recalls, and field actions.

Leadership & Cross-Functional Collaboration:

• Lead the QARA Team: Mentor and scale the Quality & Regulatory Affairs department.
• Cross-Functional Integration: Work closely with R&D, Production, Clinical, and Project Management teams.
• Stakeholder Communication: Provide regulatory and quality insights to executive leadership, investors, and external partners.

Education, Qualifications and Experience:

• Background in engineering, life sciences, or regulatory sciences.
• 5+ years of experience in Quality & Regulatory Affairs for medical devices, with at least 2+ years in a leadership role.
• Proven track record of leading MDR and/or FDA submissions, including successful CE Mark and/or 510(k)/PMA approvals.
• Deep knowledge of ISO 13485, 21 CFR Part 820, MDR (EU 2017/745), and ISO 14971.
• Experience leading Notified Body audits and/or FDA inspections, and internal/external audits.
• Strong understanding of clinical regulatory requirements, including Clinical Evaluation Reports (CER) and Post-Market Surveillance (PMS).
• Ability to build and scale regulatory and quality functions in a fast-moving startup environment.
• Excellent communication and leadership skills, with the ability to influence executive teams and external stakeholders.
• Fluency in English.

This is a great opportunity to make a strong impact within the company, contribute to your personal and professional development, and work in a flexible environment that offers ample training opportunities, clear career progression, and continuous goal setting and follow-up throughout the year.