Senior Quality & Regulatory Affairs Leader – Help Shape the Future of Skin Cancer Treatment! Are you driven to make a real difference in patient care? We’re partnering with a pioneering MedTech dedicated to revolutionising non-melanoma skin cancer (NMSC) treatment. Their non-invasive, painless solutions are transforming the field, and they’re looking for an accomplished Quality & Regulatory Affairs Leader to lead their regulatory strategy in Munich, Germany. Why You’ll Love This Role: Transformative Impact : Shape regulatory pathways in Europe, Australia, South Africa, and the U.S., playing a vital role in making innovative treatments accessible globally. Leadership Opportunity : Lead, mentor, and build a high-impact team while setting the company up for regulatory success in emerging markets. Growth Potential : Join an ambitious, agile team at a rapidly scaling business with immense growth opportunities. What You’ll Do: Develop and lead Quality System strategies to maintain and exceed regulatory compliance. Mentor and guide junior team members, fostering a collaborative and growth-focused environment. Direct end-to-end regulatory submissions for market approvals, including major new markets. Act as the primary contact for regulatory bodies in Europe, the U.S., and other key regions. Prepare and empower teams for regulatory audits, driving ongoing improvement and readiness. Oversee and coordinate external resources, including consultants and regulatory advisors. Optimise and streamline quality and regulatory processes for efficient, global compliance. Required Qualifications Degree in engineering, biomedical sciences, or a related field (Master’s or MBA is highly valued). 4+ years of hands-on experience in quality management and regulatory affairs for medical devices. Demonstrated success in managing submissions, technical documentation, and market approvals (including MDD/MDR, De Novo, and 510(k) processes). In-depth knowledge of medical device QMS (ISO 13485 / 21 CFR 820) and experience leading audits with notified bodies. Familiarity with essential standards such as ISO 14971, ISO 60601, or ISO 62366. Sounds like a fit? Click apply. Please note, only candidates with the required experience will be considered.