Director, Regulatory Affairs (f/m/d)

Das ist der Job

It’s a cause that unites and inspires us.

Darum lohnt es sich

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.

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 doingLead global regulatory activities to ensure compliance with FDA 21 CFR 820, ISO 13485, and international medical and non-medical device regulationsDefine and implement regulatory strategies across the full product lifecycle, from development to post-marketPartner with Product Management, Logistics, and Engineering teams to ensure compliant product development and global market accessEstablish and optimize global processes for trade compliance, import/export, and supply chain regulatory requirementsGuide and mentor a team of hardware and software development engineers, providing regulatory expertise across projects such as respiratory, imaging, and cardiac safety solutionsAssess regulatory impact of changes to design, materials, labeling, software, and suppliersSupport regulatory submissions, including FDA 510(k) filings and international product registrationsReview and approve product labeling, technical documentation, and marketing materials to ensure regulatory alignmentParticipate in internal, external, and vendor audits and contribute to corrective and preventive action initiativesAct as Person Responsible for Regulatory Compliance (PRRC) under MDR requirementsOversee the development and maintenance of SOPs and work instructions aligned with global standardsSupport post-market surveillance, vigilance reporting, and continuous improvement activitiesWhat we look forMaster’s degree in Engineering, Life Sciences, or a related technical field6+ years of experience in the medical device industry4+ years of experience in Regulatory Affairs within medical devices or pharmaceutical products3+ years of proven leadership experience managing or guiding teamsStrong 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 inspectionsUnderstanding of clinical trial environments and GCP is highly desirableExcellent analytical, organizational, and communication skillsFluency in English and GermanDetail-oriented with strong problem-solving capabilities and the ability to manage complex regulatory challengesAt Clario, part of Thermo Fisher Scientific, our purpose is to transform lives by unlocking better evidence.

Whether you're advancing clinical science, building innovative technology, or supporting our global teams, your work helps bring life-changing therapies to patients faster.SummaryLocation: Estenfeld, GermanyType: Full time 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.

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. It’s why we come to work—and how we empower our people to make a positive impact every day.