Director, Regulatory Affairs (f/m/d)

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.

What We Offer • Competitive compensation • Flexible working hours and working time accounts to support work‑life balance • Hybrid work model, allowing 1-2 days of remote work per week • Support for professional development through internal and external training and certification programs • Attractive benefits – security, flexibility, support, and well‑being • Engaging employee programs Responsibilities • 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 Qualifications & Experience • 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 Overview 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.