About this role
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 activitiesWHAT 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 challengesAt 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.AnsprechpartnerNathalie FischerJetzt bewerben [ https://clarioclinical.wd1.myworkdayjobs.com/en-US/clarioclinical_careers/details/Director--Regulatory-Affairs--f-m-d-_R17870 ]