Director, Regulatory Affairs (f/m/d)

Join Clario, part of Thermo Fisher Scientific, as an Engineer, R&D Software Engineering (f/m/d) in Estenfeld and help develop innovative software solutions that support clinical research and accelerate the delivery of life-changing therapies to patients worldwide. In this role, you'll contribute to the design, development, testing, and continuous improvement of software products while working closely with cross-functional teams in an agile environment. Your work will directly impact the quality, reliability, and performance of technologies used across global clinical trials.

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, 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.