Director Regulatory Affairs

Join Clario, part of Thermo Fisher Scientific, as Director, Regulatory Affairs **(f/m/d)** and play a critical role in ensuring that innovative clinical trial technologies meet global regulatory standards - helping bring life-changing therapies to patients faster. In this role, you will shape regulatory strategy, guide cross-functional teams, and ensure compliance across global markets, making a meaningful impact on patient safety and product quality. **What we offer** * Competitive compensation. * Flexible working hours and working time accounts to support the work-life balance. * Hybrid work model, allowing for 1-2 days of remote work. * Support your professional development through internal and external training and certification programs. * Attractive benefits (security, flexibility, support and well-being). * Engaging employee programs. **What you'll be doing** * Lead global regulatory activities to ensure compliance with FDA 21 CFR 820, ISO 13485, and international medical and non-medical device regulations * Define and implement regulatory strategies across the full product lifecycle, from development to post-market * Partner with Product Management, Logistics, and Engineering teams to ensure compliant product development and global market access * Establish and optimize global processes for trade compliance, import/export, and supply chain regulatory requirements * Guide and mentor a team of hardware and software development engineers, providing regulatory expertise across projects such as respiratory, imaging, and cardiac safety solutions * Assess regulatory impact of changes to design, materials, labeling, software, and suppliers * Support regulatory submissions, including FDA 510(k) filings and international product registrations * Review and approve product labeling, technical documentation, and marketing materials to ensure regulatory alignment * Participate in internal, external, and vendor audits and contribute to corrective and preventive action initiatives * Act as Person Responsible for Regulatory Compliance (PRRC) under MDR requirements * Oversee the development and maintenance of SOPs and work instructions aligned with global standards * Support post-market surveillance, vigilance reporting, and continuous improvement activities **What we look for** * Master’s degree in Engineering, Life Sciences, or a related technical field * 6+ years of experience in the medical device industry * 4+ years of experience in Regulatory Affairs within medical devices or pharmaceutical products * 3+ years of proven leadership experience managing or guiding teams * Strong knowledge of FDA regulations, ISO standards, and global medical device requirements (including 510(k) submissions and MDR) * Experience interacting with regulatory authorities and supporting audits and inspections * Understanding of clinical trial environments and GCP is highly desirable * Excellent analytical, organizational, and communication skills * Fluency in English and German * Detail-oriented with strong problem-solving capabilities and the ability to manage complex regulatory challenges At Clario, part of Thermo Fisher Scientific, our purpose is to transform lives by unlocking better evidence. It’s a cause that unites and inspires us. It’s why we come to work—and how we empower our people to make a positive impact every day. Whether you're advancing clinical science, building innovative technology, or supporting our global teams, your work helps bring life-changing therapies to patients faster.