Director, Regulatory Affairs (f/m/d)
Clario · Estenfeld
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.